Wavier Of Registration

Procedure of applying for Wavier of Registration (WOR)

Those who are willing to apply for Waiver of registration for Medical Device please be kindenough to submit your properly filled application form and relevant documents to office of Sate Ministry of Production, Supply and Regulations & Pharmaceuticals.

Download WOR Application from here :WOR Application

Documents Required for Waiver of Registration.

Mandatory Documents

Request Letter from the Applicant
Completed Waiver of Registration Application
Commercial invoice / Proforma Invoice
Letter of Authorization from the manufacturer
Product Information Leaflet / Catalogs
Labels of the product
Relevant Test Reports for the Applied Product
Free sale Certificate issued by Health Authority of Country of Origin of the Product
ISO certificate for quality management system
CE self-declaration by manufacturer/ EC certificate for full Quality Assurance system
Report of Technical Evaluation Committee (TEC)
Approval of Procurement Committee

Where Applicable

Agency transfer letter issued by NMRA
Sample import license issued by NMRA
Certificate of Registration issued by NMRA
Registration of Medical Council – Sri Lanka
Ethic review committee approval(Applicable for research items)
No Objection Letter (NOL) from local agent – (For the products already registered to another Local Agent)
Sri Lanka Custom Detained Document
Recommendation of Professional bodies
Request of Professional bodies

Note: Incomplete application will not be tabled to WOR Committee.

Waiver of Registration Committee - Device (January 2024 to March 2024)

Waiver of Registration Committee - Device 13/01/2024 & Waiver of Registration Committee - 13/01/2024 - S.P.C

Waiver of Registration Committee - Device 17/02/2024 & Waiver of Registration Committee - 17/02/2024 - S.P.C

Waiver of Registration Committee - Device 23/03/2024 & Waiver of Registration Committee - 23/03/2024 - S.P.C

Waiver of Registration Committee - Device (October 2023 to December 2023)

Waiver of Registration Committee - Device 05/12/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
01	22/11/2023	MD/1858/11/2023	Reagent for Hematology Analyzer	As per the invoice	10043701, date: 18/08/2023 , 10043702, date: 18/08/2023	33,515.00 + 1,370.00	Hemas Surgicals & Diagnostics (Pvt) Ltd	Nihon Kohden - Japan	For Sri Lanka Air Force	Registered Manufacturer with NMRA. Requested to import reagents and controls for already installed Nihon Kohden analyzers in Air force hospitals.	Recommended with condition. Advised to submit the dossier for registration within 03 months.
02	22/11/2023	MD/1861/11/2023	Active Surgicals Power Tools, Blade & Burs for General Surgery (Brand: ConMed)	12	4275735, date: 25/10/2023, 4276228, date: 26/10/2023, 4277758, date: 27/10/2023, 4280668, date: 31/10/2023	959.00+1113.00+13608.00+1694.00	Hemas Surgicals & Diagnostics (Pvt) Ltd	Leagal - ConMed Corporation - USA, Physical - Linvatec Corporation d/b/a ConMed Linvatec - USA	For Lanka Hospital Diagnostics	Previously registered product with Zodiac Medicals & Agency transferred to Hemas Surgicals. Applied for Sample Import License on 14.11.2023 to NMRA.	Recommended with condition. Advised to submit the dossier for registration.
03	22/11/2023	MD/1859/11/2023	Anti-Human IgG (H+L), highly cross adsorbed-Peroxidase antibody produced in goat (Brand: Sigma) (Model: SAB3701361-1MG)	1	8206451278, date: 15/11/2023	EUR 382.00	Neochem Lifesciences (Pvt) Ltd	Sigma Aldrich - Germany	For Faculty of Medicine, University of Colombo	Manufacturer is not registered with NMRA. Request for research purpose from University of Colombo.	Recommended only for this consignment.
04	22/11/2023	MD/1860/11/2023	QClamp PIK3CA Mutation Detection Test (30 Samples)	2	103023AP, date: 30/10/2023	USD 1,440.40	Tharini Cabraal, Faculty of Science, University of Colombo	Diacarta Inc - United States of America	For Research	Manufacturer is not registered with NMRA. Request for an undergraduate research of University of Colombo.	Recommended only for this consignment.
05	04/12/2023	MD/1874/12/2023	Computed Tomography System / CT Scanner with standard Accessories and Spare Parts	1	Z448710, date: 22/11/2023	Yen 20,200.00	Mediquipment Limited	Canon Medical Systems Corporation - Japan	For Teaching Hospital - kurunegala	Previously registered product with NMRA. (Alexion CT Scanner) and discontinued the model. Request to supply Spare Parts for installed Alexion Series CT Scanner - TH - Kurunegala.	Recommended only for this consignment.
06	04/12/2023	MD/1875/12/2023	Sterilizer System and Standard Accessories and Spare Parts	As per the invoice	8085414695, date: 28/11/2023	USD 22,430.94	Mediquipment Limited	Getinge Sterilization AB - Sweden	For Sri Lanka Covid 19 Emergency Response and Health Systems Preparedness Project	Registered Product with NMRA. Request to supply Spare Parts for HS-66; discontinued model.	Recommended only for this consignment.
07	30/11/2023	MD/1868/11/2023	Human Cys-C (Cystain C) ELISA Kit, Human BMG/B2-MG ( Beta-2-Microglobulin) ELlSA Kit, Human KIM-1 (Kidney Injury Molecule 1) ELISA Kit, Human AMBP Elisa Kit, Human NGAL ELISA kit	4+4+4+4+4	ED20231121SRA, date: 21/11/2023	U$ 4,212.00	Biomedite (Pvt) Ltd	Wuhan Elabscience Biotechnology Co.Ltd - China	For University of Sri jayawardenepura (Research Purpose)	Manufacturer is not registered with NMRA. No registered Sources available.	Recommended only for this consignment.
08	30/11/2023	MD/1866/11/2023	Dental Imaging System , Fire CR dental reader with accessories & Spare Parts	As per the invoice	TD-231023-D10+3 , date: 09./11/2023	$28,660.00	Access International (Pvt) Ltd	Digiray Corp - Korea	For the Department of Health Services - Southern Province and Eravur Multi Purpose Co-Operative Society Ltd	Applied for product registration. (D-5038) on 24/10/2023.	Not recommended. Advised to expedite the registration.
09	14/11/2023	MD/1828/11/2023	Medical Devices/Equipments	As per the invoice	SO-019210, date: 01/11/2023	USD 103,787.30	Ministry of Health	Imres b.v - Netherland.	Donation from United Nations Population Fund to government of Sri Lanka		Recommended only for this consignment. (For device only)
10	15/11/2023	MD/1829/11/2023	Vaccine Refrigerator (With Voltage Stabilizer / Spare Parts	50 + 5	SWW9015945, date: 14/11/2023	USD 70,050.00	Ministry of Health	Qingdao Haier Biomedical Co.ltd - China	Donation from United Nations International Children's Emergency Fund to government of Sri Lanka		Need proper details and documents.
11	25/10/2023	MD/1795/10/2023	Bioline LF FTS (Filariasis Test Strips) Kits	600 PCS	AWB No: 6485593833, date: 10/11/2023	USD 3421.98	Ministry of Health	World Health Organization - Dilhi	Donation to Anti Filariasis Campaign		Recommended only for this consignment.
12	17/11/2023	MD/1840/11/2023	Indicating FTA Classic Card Pack of 25. Origin UK (HS Code 48239085)	76	258278, date: 23/10/2023	USD 11,979.88	Ministry of Health	Camlab Limited - UK	Donation to government of Sri Lanka		Recommended only for this consignment.
13	21/11/2023	MD/1845/11/2023	Medical Devices/Equipments	As per the invoice	HSC/USAWAS/2301, date: 01/11/2023	$1,124.00	Ministry of Health (Hospital Services Council)	Hospital Services Council of Greater Washington Area - USA	Donation		Recommended only for this consignment and advised to submit the distribution list.
14	21/11/2023	MD/1846/11/2023	Medical Devices/Equipments	As per the invoice	HSC/AU/2303, date: 02/11/2023	AUD 1,326.55	Ministry of Health (Hospital Services Council)	Hospital Services Council Australia Incorporated - Australia	Donation		Recommended only for this consignment and advised to submit the distribution list.
15	21/11/2023	MD/1847/11/2023	Medical Devices/Equipments	As per the invoice	00501730360, date: 07/11/2023	USD 14,071.20	Ministry of Health	United Nations Children's Fund - Denmark	Donation		Recommended only for this consignment.
16	21/11/2023	MD/1848/11/2023	Microplate Washer MW-12A, G-plug, 100-240VAC, Complete set	6	0012623, date: 09/10/2023	EUR 13,837.50	Ministry of Health	United Nations Children's Fund - Denmark	Donation		Recommended only for this consignment.
17	06/11/2023	MD/1850/11/2023	Fetal Bovine Serum (Brand: Sigma)	1	8206394301, date: 26/07/2023	EUR 119.00	Prof. S.K.M.K. Harapathdeniya, Faculty of Indigenous Medicine - University of Colombo	Sigma Aldrich - Germany	For Research Purpose	Manufacturer or Local Agent not registered with NMRA. No registered Sources available.	Recommended only for this consignment.
18	06/11/2023	MD1851/11/2023	L-Asparagine (Brand: Sigma)	2	8206390169, date: 18/07/2023	EUR 434.00	Dr. Senathanie Ranasinghe, Coconut Research Institute	Sigma Aldrich - Germany	For Research Purpose	Manufacturer or Local Agent not registered with NMRA MDR Division. No registered Sources available.	Recommended only for this consignment.
19	23/11/2023	MD/1853/11/2023	Oxygen Cylinder 15L, Oxygen Cylinder Connector, Oxygen Regulator, BULL Socket	1050+300+300+150	Annex-II		Ministry of Health	Sri Lanka Embassy in Beijing	Donation		Pending Decision. Safety should be evaluated prior approval. Advised to submit samples for clinical evaluation.
20	30/11/2023	MD/1867/11/2023	FTA Cards	76	258278, date: 23/10/2023	USD 111,979.88	Medical research Institute	World Health organization - Malaysia	Donation to MRI		Recommended only for this consignment.
21	22/11/2023	MD/1855/11/2023	ICU Hospital Beds	157	19112023, date: 19/11/2023		Ministry of Health (Mahakaruna Buddhist Society)	Mahakaruna Buddhist Society - Singapore	Donation		Recommended only for this consignment and advised to submit the beneficiaries list to the NMRA.
22	22/11/2023	MD/1856/11/2023	CX33RFS2- Microscope frame for transmitted microscopy with LED illumination, trinocular tube, a pair of eyepiece 10X with helicoid adjustment..	10	203269556, date: 10/10/2023	USD 19,328.00	Ministry of Health	World Health Organization, Global Procurement and Logistics - Malaysia	Donation from WHO-Malaysia		Pending Decision. Need necessary details prior to approval.
23	24/11/2023	MD/1857/11/2023	Glucometer Tests Kits	As per the invoice	SO-018585, date: 20/07/2023	USD 98,420.00	Ministry of Health	Imres b.v - Netherland.	Donation		Recommended only for this consignment.
24	23/11/2023		Medical Devices/Equipments	3 + 3	SO-019532, date: 09/08/2023	5,119.95	Ministry of Health	Imres b.v - Netherland.	Donation (Extention)		Recommended the WOR approval extension.
25	16/11/2023		Female pelvis models and perineum cutting and suture trainer models	200 PC	2301802711, date: 05/09/2023	17936.83	Ministry of Health	3B Scientific GmbH - Germany	Donation (Extention)		Recommended the WOR approval extension and advised to submit distribution list.
26	16/11/2023		Ultrasound, Scanner, digital, portable with printer and accessories	9	288, date: 11/05/2023	43200	Ministry of Health	Fazzini - Italy	Donation (Extention)		Recommended the WOR approval extension.
27	29/11/2023	MD/1865/11/2023	Goat-Anti-Rat 1gM-UNLB; 1mg	2	Q19815	$230.00	Prof. Prasanna Galhena, Director, Institute of Biochemistry, Molecular Biology & Biotechnology (IBMBB)	My BioSource - USA	For resurch purpose.		Recommended only for this consignment.
28	01/12/2023	MD/1871/12/2023	Thermo Scientific Block 28x15ml for dry baths and heating blocks replacement	4	EXP-PI-2023/749, date: 22/11/2023	USD 40.00	Ministry of Health	Fleischhacker - Singapore	Donation		Recommended only for this consignment
29	01/12/2023	MD/1872/12/2023	Scale, mother,child, electronic, 200kg	30	3073656, date: 15/11/2023	USD 3,579.90	Ministry of Health	Fleischhacker GmbH & Co.KG - Schwerte	Donation		Not coming under NMRA purview. (Medical Device)
30	01/12/2023	MD/1873/12/2023	Re-Conditioned manual wheelchairs complete with cushions, Reconditioned powered wheelcharscomplete with cushions and support seat inserts, Crutches and walking aids	200 + 10 + 100	Equip-Charity-17-2, date: 27/11/2023	E 2,375.00	The Meththa Rehabilitation Foundation	The MeththaFoundation - UK	Donation		Recommended only for this consignment and advised to submit distribution list.
31	04/12/2023	MD/1876/11/2023	Standard Q Filariasis Antigen Test Kit	40 Kits	N/A	Rs. 2,675,744.80	International Organization for Migration	SD Biosensor Inc - Korea	For IOM	Manufacturer is registered with George Steuart Health (Pvt) Ltd for different product. No valid registration for Filariasis test kits.	Recommended with condition. Subject to submission of product dossier.

Waiver of Registration Committee - Device 05/12/2023 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
1	06/11/2023	MD/1825/11/2023	Extention Tube (Brand : 31,745 NOS)	31,745	LP/DHS/RS/RQ/29/552CP/29/22, date: 30/06/2023	LKR 3,904,635.00	New Arumed (Pvt) Ltd	Global Medikit Limited - India	SPC Tender	Manufacturer is registered with NMRA.	Pending Decision. Advised to re-evaluate the product with College of Aneasthesiologists of Sri Lanka.
2	27/04/2023	MD/1521/05/2023	Elastic Adhesive Bandage BP (1993)	150,000 Roll	DHS/RS/EP/74/2022, date: 31/03/2023	LKR 90,000,000.00	Abiman Medical and Surgical Distributors	Medicare Hygiene Limited - India	SPC Tender	Samples are recommended by the College of Surgeon.	Not Recommended. Due to the availability of many NMRA registered sources.
3	23/10/2023	MD/1802/10/2023	Cervical Wooden Spatula Ayre type (or Similar)	350,000 NOS	LP/DHS/RSS/RQ/293/705DR/2021, date: 09/10/2023	LKR 4,987,500.00	Marco Lab (Pvt) Ltd	Jiangsu Hanheng Medical Technology Co.Ltd - China	SPC Tender	Manufacturer or Local Agent not registered with NMRA. Submitted to WOR Committee held on 14/11/2023 and Decision was Recommended with condition. Subject to submission of Dossier for product registration.	Not recommended. Advised to either procure from registered sources or submit the dossier for product registration.

Waiver of Registration Committee - Device 14/11/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
1	03/11/2023	MD/1733/09/2023	Radioactive Materials MCD 33VTc-99m Drytec Generator 6GBq	26	CA/108424D/0101/001 (MSD/SB3/R/17/2021)	USD 39,047.57	Medical Supplies Division	Crown Agents (Sunpro Healthcare)	For NIU - Lady Ridgway Hospital		Pending Decision. Inform to the Chairman and Refer to MDEC.
			DMSA Agent Mercapton DMSA	36 Vials
			Bridatec Bromo-Biliaron	12 Vials
			Mag3	36 Vials
			Nanocole	12 Vials
2	03/11/2023	MD/1732/09/2023	Radioactive Materials 99m TC Generator	26	CA/108424D/0106/001, date: 05/04/2022	USD 64,821.90	Medical Supplies Division	Crown Agents (Sunpro Healthcare)	For NIU - Karapitiya		Pending Decision. Inform to the Chairman and Refer to MDEC.
			MDP Kits - Skeleton	16
			DTPA Kits	25
			DMSA Kits	16
			Mag 3 Kits	3
			Decontamination Kits	1
			Quality Control Kits	25
3	05/09/2023	MD/1751/09/2023	Hematology Analyzer (Brand: Abbott)	2	ADD/PF/A668/2023/PAK/GMBH, date: 03/07/2023	US $ 24863.00	Hemas Surgicals & Diagnostics (Pvt) ltd	Legal : Abbott Laboratories - USA, Physical : BIT Analytical Instrument GMBH - Germany	For Hemas Hospital (Pvt) Lyd	Registered product with NMRA & Valid till 25.01.2024. Autoloader for the analyzer not include in the attachment. Not applied for variation.	Recommended only for this consignment. Advised to apply for variation.
4	23/10/2023	MD/1801/10/2023	Spectra Optia Exchange Set/ Spectra Optia IDL Set (Brand: Terumo)	36 + 150	950096931, date: 11/10/2023	USD 24,180.00	Hemas Surgicals & Diagnostics (Pvt) ltd	Terumo BCT Inc - USA	For National Blood Transfusion Services	NMRA registered product and manufacturing site change. Applied for product registration. (D-4959)	Not recommended. Expedite the registration.
5	23/10/2023	MD/1803/10/2023	Adult Velcro Cuff (Brand: Accoson)	Invoice Qty = 55, RDHS-, Batticaloa purchase order Qty = 50	1409, date: 10/08/2023	GBP 470.75	Esna Allied Enterprises (Pvt) ltd	A.C.Cossor & Son (Surgical) Ltd - United Kingdom	For Ragional Directorate of Health Services, Batticaloa	NMRA registered product and manufacturing site has been changed. Applied for site registration on October 2023. (FMSA/MD/2023/491) Request letter from RDHS - Batticaloa available.	Recommended only for this consignment.
6	23/10/2023	MD/1804/10/2023	Swiss Litho Clast Master - Lithotripter System with Standard Accessories	13+10	00011237, date: 25/09/2023	EUR 4,202.00	Chatham House (Pvt) Ltd	E.M.S. Electro Medical System S.A, - Switzerland	Dr. Dimantha De Silva, Snr. Urologist Surgeon, teaching Hospital - Karapitiya / Dr. Niroshan Senevirathne, Sri Jayawardenepura Hospital	NMRA registered product and expired on 29.06.2023. (D/524) Not applied for the renewal of registration. Around 05 registered sources available.	Recommended only for this consignment. Subject to submission of Dossier for product registration.
7	30/10/2023	MD/1805/10/2023	Wheelchairs/ Artificial Limbs / Orthopaedic and diabetic footwear	866	Equip-Charity-17, date: 10/09/2023	E 4400.00	Meththa Rehabilitation Foundation	The Meththa Foundation - UK	Meththa Rehabilitation Foundation		Recommended Only for this consignment. (Recommended Only for Artificial Limbs and Footwear)
8	10/11/2023	MD/1810/11/2023	Whole Blood donation mixing/Weighing device	3 pce	8521886843, date: 10/10/2023	EUR 10,350.00	Premium International (Pvt) Ltd	Fresenius Kabi AG - Germany	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
9	10/11/2023	MD/1811/11/2023	Automated blood component seperator	As per the invoice	8521886386, date: 13/09/2023	EUR 21,500.00	Premium International (Pvt) Ltd	Fresenius Kabi AG - Germany	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
10	10/11/2023	MD/1812/11/2023	Portable tube seales for high quality seals	02 PCE	8521886386, date: 13/09/2023	EUR 4,100.00	Premium International (Pvt) Ltd	Fresenius Kabi AG - Germany	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
11	10/11/2023	MD/1813/11/2023	Manual Plasma Extractor	2	8521886386, date: 13/09/2023	EUR 1,760.00	Premium International (Pvt) Ltd	Fresenius Kabi AG - Germany	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
12	10/11/2023	MD/1814/11/2023	Donation and apheresis Chair	6.00 pce	8521886867, date: 12/10/2023	EUR 10,950.00	Premium International (Pvt) Ltd	Fresenius Kabi AG - Germany	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
13	10/11/2023	MD/1815/11/2023	Vertical Autoclave	1	XHC230927003, date: 15/10/2023	USD 1275.00	Premium International (Pvt) Ltd	Shinva Medical Instrument Co.Ltd - China	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
14	10/11/2023	MD/1816/11/2023	Autoclave	1	XHC230927003, date: 15/10/2023	USD 1576.00	Premium International (Pvt) Ltd	Shinva Medical Instrument Co.Ltd - China	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
15	10/11/2023	MD/1817/11/2023	Plasma Thawer with cover	1	8265, date: 21/09/2023	E 5,077.00	Premium International (Pvt) Ltd	Helmer Scientific - USA	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
16	10/11/2023	MD/1818/11/2023	Platelet Incubator (With Accessories)	4	8265, date: 21/09/2023	E 11,590.00	Premium International (Pvt) Ltd	Helmer Scientific - USA	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
17	10/11/2023	MD/1819/11/2023	Tissue embedding system - embedding module & cryo module	2 sets	230800130, date: 14/09/2023	JPY 700.00	Premium International (Pvt) Ltd	Sakura Seiki Co.ltd - Japan	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
18	10/11/2023	MD/1820/11/2023	Automated slide stainer with cover slipper (& Link system)	1 pcs + 2 sets	230800130, date: 14/09/2023	JPY 5,410.00	Premium International (Pvt) Ltd	Sakura Seiki Co.ltd - Japan	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
19	10/11/2023	MD/1821/11/2023	Slide Warmer	1 Set	230800130, date: 14/09/2023	JPY 150.00	Premium International (Pvt) Ltd	Sakura Seiki Co.ltd - Japan	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
20	10/11/2023	MD/1822/11/2023	Water bath round model (Tissue flotation water bath)	1 Set	230800130, date: 14/09/2023	JPY 210.00	Premium International (Pvt) Ltd	Sakura Seiki Co.ltd - Japan	Ministry of Health throught New Maternity Hospital - Karapitiya		Not recommended and advised to register the product.
21	13/11/2023	MD/1823/11/2023	Non-Woven Chesive Bandage and Kinesiology Type	17552	23/66086, date: 23/08/2023	USD 6456.69	CIC Holdings PLC	Suzhou Sunmed Co.ltd - China		Manufacturer not registered with NMRA. Not applied for registration.	Not recommended and advised to register the product.
22	13/11/2023	MD/1824/11/2023	Capillary Cartridge (Brand: Sebia)	Invoice Qty : 8, Order Qty : 5	FLII012310PRF00000189, date: 23/10/2023	EUR 2080.00	Analytical Instruments (Pvt) ltd	Sebia - France	For several government hospitals in sri lanka ( TH-Kalutara, TH-Batticaloa, NH - Kandy, Base hospital - Kalutara		Not recommended. Advised to apply for Variation.
23	28/08/2023	MD/1726/09/2023	Hospital Beds (2 Functional Hospital Beds / 3 Function Electric Hospital Beds)	10 + 1	174397547501029504, date: 07/06/2023	$1,873.88	Suwabawana Hospital	Beijing Xindalikang Medical Equipment C.ltd - Hong Kong	For For Suwabawana Hospital Use	· Manufacturer not registered. · Registered sources available. (05) Submitted to WOR Committee held on 10/10/2023 and Decision was Not recommended and advised to register the product. Advised to purchase from registered sources.	Not recommended and advised to register the product. Advised to purchase from registered sources.
24	22/09/2023	MD/1759/09/2023	First Aid Kits Hard Case	5100	UN2399G, date: 09/09/2023	$ 27,132.00	Omaya International (Pvt) Ltd	Ningbo Tianbo First Aid Product Co.Ltd - China	For Michelin Lanka (Pvt) Ltd	· Manufacturer is not registered with NMRA. To be imported to distribute as gift items among the employees of Michelin Lanka (Pvt) Ltd. Submitted to WOR Committee held on 10/10/2023 and Decision was Not recommended and advised to register the product.	Not recommended and advised to register the product.

Waiver of Registration Committee - Device 14/11/2023 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
01	23/10/2023	MD/1802/10/2023	Cervical Wooden Spatula Ayre type (or Similar)	350,000 NOS	LP/DHS/RSS/RQ/293/705DR/2021, date: 09/10/2023	LKR 4,987,500.00	Marco Lab (Pvt) Ltd	Jiangsu Hanheng Medical Technology Co.Ltd - China	SPC Tender	Manufacturer or Local Agent not registered with NMRA.	Recommended with condition. Subject to submission of Dossier for product registration.
02	13/07/2023	MD/1644/07/2023	Root Canal Sealer , Resin Based, for permanant filling of root canal	4200	LP/DHS/S/WW/237/900KP/21, date: 29/06/2023	LKR 16,548,000.00	Ogaki & Company	Shiva Products - India	SPC Tender	Appeal - Submitted to WOR Committee held on 12/08/2023 and Decision was Not recommended and advised to register the product. Again Submitted to WOR Committee held on 10/10/2023 and Decision was Not recommended and advised to expedite the registration.	Recommended Only for this consignment. (At the decision of the College of Dentistry and Stomatology of Sri Lanka. If approved, WOR can be given.)

Waiver of Registration Committee - Device 10/10/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
1	04/09/2023	MD/1750/09/2023	Gazue Bandages / Cotton Roll / 100PCS/BAG / Cotton Bandages / Elastic Bandages / Non Women Tape / Zinc Oxide Adhesive Tape	As per the invoice	CT23017, date: 21/07/2023	US$ 20,836.60	Tomahawk Medical (Pvt) Ltd	Suzhou Courge Trading Co. Ltd - China.	For a Medical Camp	· Manufacturer and Local Agent not registered with NMRA. · Registered sources available for all requested products.	Not recommended and advised to register the product. Advised to purchase from registered sources.
2	04/09/2023	MD/1752/09/2023	Reagents for Hematology Analyzer	As per the invoice	10043701, date: 18/08/2023 , 10043702, date: 18/08/2023	USD 33,515.00 + USD 1,370.00	Hemas Surgicals & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Sri Lanka Air Force	· Registered Manufacturer. · Agency Transfer from TMI Solutions to Hemas Surgicals. · Request to import reagents for installed analyzer. · Previous Ref: no: DVR/9922, DVR/9923, DVR/9924, DVR/9926, DVR/9928	Not recommended and advised to expedite the registration.
3	18/09/2023	MD/1763/09/2023	Spare Parts for Bedside Monitor	As per the invoice	10038450, date: 07/06/2023, 10043171, date: 08/07/2023	USD 520.00 + USD 29,923.68	Hemas Surgicals & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Faculty of Medicine - University of Kelaniya , Department of Health Services - Northwestern Province	· Manufacturer and Local Agent registered. · Applied for registration. NMRA Ref: No: D-4694.	Recommended only for this consignment.
4	21/09/2023	MD/1765/09/2023	Aortic Valve Repair Kit and Pen	10 + 10	SO-1005, date: 19/07/2023	USD 6,930.25	Hemas Surgicals & Diagnostics (Pvt) ltd	Legal : Sanamedi Inc - Japan, Physical : HANTEL Technologies inc - USA	Department of Cardiothoracic Surgery - Teaching Hospital Kandy.	· Manufacturer not registered with NMRA. · No registered sources for the product. · Request from Teaching Hospital - Kandy. · Previously WOR was given on 2019. (NMRA/EC/WOR/DVR/105/19)	Recommended only for this consignment. (Limited Quantity) Advised to apply for registration.
05	03/10/2023	MD/1780/10/2023	Reagent for Immunoassy Analyzer	2+3+13	ADD/PF/A704/2023/PAK/GMBH - 08/09/2023	US $ 6825.00	Hemas Surgicals & Diagnostics (Pvt) ltd	Abbott GmbH - Germany	For National Hospital of Sri Lanka	· Registered product with NMRA (Ref: No: D-1620-RR). · Request to Amend the reagent list not submitted to the NMRA.	Not recommended and advised to apply for certificate amendment.
06	21/09/2023	MD/1761/09/2023	Orthopeadic Drill System Componentes	As per the invoice	20230901PF/01.09.23	AED 68,901.17	B. Braun Lanka (Pvt) Ltd	Aesculap AG - Germany	For several government hospitals. (For NHSL - Colombo, District General Hospital - Polonnaruwa, Sri Jayawardenepura General Hospital, National Hospital - Kandy, Colombo South Teaching Hospital - Kalubovila, District General Hospital - Matale)	Exported items for repairing.	Recommended only for this consignment.
07	14/09/2023	MD/1764/09/2023	Sterilizer - Sterilizer System and Spare Parts, Standard Accessories (Getinge HS 66 Hospital Sterilizer)	As per the invoice	8085414114, date: 21/08/2023	USD 15,878.16	Mediquipment Limited	Getinge AB - Sweden	For Base Hospital - Tissamaharama	· Previously registered product with NMRA. (DVR-11509) · Applying due to the discontinuation of the product by manufacturer and requirement for repair of on installed machine.	Recommended only for this consignment.
08	03/10/2023	MD/1781/10/2023	Fetal Monitor with Standard Accessories, Consumables and Spare Parts	As per the invoice	NJH23SR-0921-1, date: 21/09/2023	USD 2519.00	Mediquipment Limited	Guangzhou Sunray Medical Apparatus Co.Ltd - China	For General Hospital - Ampara	· Previously registered product with NMRA & expired. (Ref: DVR-13833) · Manufacturing site changed and applied to the NMRA. (ReF: FMSA/MD/2023/429) · Request to repair the installed machine is available from General Hospital - Ampara.	Recommended only for this consignment.
09	21/09/2023	MD/1766/09/2023	Platelet Aggregometer with Standard Accessories & Reagents (helena) Agg RAM) (Brand: Helena)	As per the invoice	3545/0012398, date: 30/09/2023	E 2,730.49	Analytical Instrumets (Pvt) Ltd	Helena Biosciences Europe - UK	For Medical Research Institute (Research Purpose)	· Registered product with NMRA and expired on May 2022. · Not applied for renewal due to the deficiency of documentation.	Recommended only for this consignment. Advised to apply for renewal.
10	17/08/2023	MD/1689/08/2023	Orthodontic Bracket (Brand : DAMON Q)	As per the invoice	6981004, date: 17/03/2023	USD 61,920.00	La Solve (Pvt) Ltd	Ormco Corporation - USA	For Dental Treatment. (For Dr. Ajith Premaratne, Consultant Orthodontist, Asiri Surgical and Hemas Hospital / Dr. Rathnakumara Dissanayake, Consultant Orthodontists, Sirimavo Bandaranayake Teaching Hospital, Kandy)	· Sample import license from NMRA issued and Not applied for registration. · 02 registered sources available.	Not recommended and advised to register the product.
11	28/08/2023	MD/1726/09/2023	Hospital Beds (2 Functional Hospital Beds / 3 Function Electric Hospital Beds)	10 + 1	174397547501029504, date: 07/06/2023	$1,873.88	Suwabawana Hospital	Beijing Xindalikang Medical Equipment C.ltd - Hong Kong	For For Suwabawana Hospital Use	· Manufacturer not registered. · Registered sources available. (05)	Not recommended and advised to register the product. Advised to purchase from registered sources.
12	21/08/2023	MD/1698/08/2023	ABR Medical PC Platform with spare parts & Accessories (Eclipse) (Model: DPOAE20; TEOAE25; VEMP; ASSR;EP25;IA ONE Suite in one platform)	1	SQ030466, date: 14/08/2023	EUR 14,754.00 (USD 16,049.40)	J.M. Wickramarachchi & Company (Pvt) Ltd	Interacoustics A/S - Denmark	For C.R. Medi Tech Lab (Pvt) Ltd, Gampaha)	· Applied for manufacturing site registration. (NMRA ref: No. FMSA/MD/2023/439)	Not recommended and advised to register the product.
13	25/09/2023	MD/1767/09/2023	Sterile Lancet for Single Use	500,000 PCS	MD2311, date: 01/09/2023	US$ 1,750.00	Emex Medical	Shandong Lianfa Medical Plastic Products Co.Ltd - China	For a Medical Camp	· Already registered manufacturer with another local agent for a different product. (Biomedite pvt ltd) · Registered sources available for blood lancets. (More than 15)	Not recommended and advised to register the product.
14	03/10/2023	MD/1782/10/2023	Micromanipulation Pipptes (ICSI Pippetes/Holding Pipettes)	33	463430, date: 22/09/2023	EUR 0.00	A. Baur & Co. (Pvt) Ltd	Vitrolife Inc - USA	Re-export	· Applied for manufacturing site approval and NMRA decision was “awaiting data”.	Not recommended and advised to expedite the registration.
15	09/10/2023	MD/1784/10/2023	Surgical Instruments for Workshop	As per the invoice	T23-179/181DSW-C, date: 22/09/2023	$301,193.49	CIC Holding PLC	Synthes GmbH - Switzerland	For The Sri Lanka Orthopaedic Association (For Workshop)	· Surgical Instruments for a Workshop by PGIM.	Recommended only for this consignment.
16	22/09/2023	MD/1759/09/2023	First Aid Kits Hard Case	5100	UN2399G, date: 09/09/2023	$ 27,132.00	Omaya International (Pvt) Ltd	Ningbo Tianbo First Aid Product Co.Ltd - China	For Michelin Lanka (Pvt) Ltd	· Manufacturer is not registered with NMRA. · To be imported to distribute as gift items among the employes of Michelin Lanka (Pvt) Ltd.	Not recommended and advised to register the product.

Waiver of Registration Committee - Device 10/10/2023 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
01	06/02/2023	MD/1398/02/2023	Blood Lancet	800,000 NOS	DHS/ICL/X/RL/035/039SM/22, date: 16/01/2023	US $ 6,320.00	Avon Pharmo Chem (Pvt) ltd	Labex K.K International - India	SPC ICL Tender	· Manufacturing site registration application submitted to NMRA. (FMSA/MD/2023/439 · Recommended by the College of Chemical Pathologists.	Recommended for the consignment. (recommended by college of Chemical Pathologists.)
02	13/07/2023	MD/1644/07/2023	Root Canal Sealer , Resin Based, for permanant filling of root canal	4200	LP/DHS/S/WW/237/900KP/21, date: 29/06/2023		Ogaki & Company	Shiva Products - India	SPC Tender	Appeal - · Manufacturer registered with LW Medicals. All the other products were Agency Transferred to Ogaki & Company. · Other registered sources are available. · Not applied for product registration. Submitted to WOR Committee held on 12/08/2023 and Decision was Not recommended and advised to register the product.	Not recommended and advised to expedite the registration.

Waiver of Registration Committee - Device (June 2023 to September 2023)

Waiver of Registration Committee - Device 05/09/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
1	15/08/2023	MD/1680/08/2023	Medical Devices for Exhibition of the college of surgeons of SriLanka.	As per the invoice	91189315, date: 03/08/2023	EUR 10,048.28	Mega Meditech (Pvt) Ltd	Gebruder Martin GmbH & Co. KG- Germany	For Exhibition of the College of Surgeon of Sri Lanka	· Manufacture and local agent registered with NMRA. · Medical Device exhibition by college of surgeon 2022. · Re export basis.	Recommended only for this consignment. Advised to re-export after the Exhibition.
2	15/08/2023	MD/1685/08/2023	CT Tube (Toshiba Aquilion CXL)	1 Nos	BMEC/PI-2022-23/7, date: 27/07/2023	$49,800.00	Delmege Forsyth & Co. Ltd	Toshiba International Corporation - USA	Sri Lanka Army.		Recommended only for this consignment Subject to Submit no-objection letters from biomedical engineering services.
			X-Ray Tube with Housing Assembly (MRC20058 rot GS1003)	1 Nos	BMEC/PI-2022-23/4, date: 27/07/2023	$49,800.00		Philips Electronics Nederland B.V - Netherland	For Biomedical Engineering Services (For NHSL and TH Karapitiya)
			CT Tube - Philips MRC 600	1 Nos	BMEC/PI-2022-23/5, date: 27/07/2023	$49,000.00		Philips Electronics Nederland B.V - Netherland	For Biomedical Engineering Services (For NHSL and TH Karapitiya)
			X-Ray tube calibration Kits (Dose meter, filter set)	1 Nos	BMEC/PI-2022-23/6, date: 27/07/2023	$21,600.00		Philips Electronics Nederland B.V - Netherland	For Biomedical Engineering Services (For NHSL and TH Karapitiya)
3	15/08/2023	MD/1664/07/2023	Surgery Bed and Infant Radiant Warmer	01 + 02	202306001, date: 29/06/2023	USD 210.34 + USD 246.00	Senarathna Holdings (Pvt) Ltd	Zui Bang Hong Kong Limited - China	For Medihelp Hospital (Pvt) Ltd	· Manufacturer or local agent not registered with NMRA. · Other registered sources are available for radiant warmers and surgery bed.	Not recommended and advised to register the product.
4	18/08/2023	MD/1686/08/2023	Zinc Oxide 110gm , Soothenol Euhenol 15ml, Non-setting Ca(OH2)	2000 + 2000 + 2000	# 222, date: 12/07/2023	$6,735.00	Oseth Pharmaceuticals	Dengen Health Care (Pvt) Ltd - India	For HSEP. (from ADB)	· Recommended by college of Dentistry and Stomatology	Recommended only for this consignment.
5	21/08/2023	MD/1690/08/2023	Dental Chair Unit with Standard Accessories	5	VT20230526, date: 2023/08/08	$4,430	Reborn Medicom Company (Pvt) Ltd	Foshan Voten Medical Technology Co.ltd - China	For dental. (Dr. Sandyanl Amarasingha, Dental Surgeon)	· Manufacturer Local Agent not registered. · Other registered sources available.	Not recommended and advised to register the product.
6	21/08/2023	MD/1691/08/2023	Hemoglobin Analyzer system with standard accessories, spare parts and comsumables (D-10 Hemoglobin Testing System and D-10 printer installation kit.)	03 + 03	BRI/CDG/32/23, date: 17/07/2023	USD 33,900.00	Emar Pharma (Pvt) Ltd	Biorad Laboratories - USA.	For Nawaloka Care Laboratories (manufacturing site Change)	· Previously registered product and valid till 2027. · Manufacturing site changed. Biorad labor otories - Singapore. · Site registration completed. FMSA/MD/2023/413)	Recommended only for this consignment. Advised to register the product.
7	21/08/2023	MD/1692/08/2023	Cryoprotectant for the cryopreservation of human cells and tissues for transplantation.	10	105875, date: 10/08/2023	E1,085.00	Emar Pharma (Pvt) Ltd	WAK-Chemie Medical GmbH - Germany	For Lady Ridgeway Hospital for children	· No other registered sources. · Previously WOR (NMRA/EC/WO/DVR/317/2022)	Recommended only for this consignment. Submit the file for registration.
8	18/08/2023	MD/1693/08/2023	DTPA, MDP Kits, DMSA	120 + 120 + 60	CA/108424D/0123/001, 15/05/2023	Euro 10,771.19	Medical Supplies Division	National Centre for Nuclear Research Radiostope Center POLATOM - Poland	For MSD (For NMU - Peradeniya) (Not a donation)	· No other registered sources for importing radioactive materials.	Recommended only for this consignment.
9	18/08/2023	MD/1694/08/2023	Technetium - 99m Drytec Generator - 10GBq	26	CA/108424D0122/001, date:15/05/2023	USD 39,796.08	Medical Supplies Division	Ezacibasi-Monrol Nuclear Products Co - Turkey.	For MSD (For NMU - Peradeniya) (Not a donation)	· No other registered sources for importing radioactive materials.	Recommended only for this consignment.
10	18/08/2023	MD/1695/08/2023	THS 125-I RIA Kits (100 Tubes Kit) , Free Thyroxin (FT4) 125-I RIA Kits (100 Tubes Kit)	6000 + 6000	CA/108424D/0121/001, date: 15/05/2023	USD 11,780.59	Medical Supplies Division	Beckman Coulter - Czeck Republic	For MSD (For NMU - Peradeniya) (Not a donation)	· No other registered sources for importing radioactive materials.	Recommended only for this consignment.
11	25/08/2023	MD/1701/08/2023	Coccidioides IDCF ID Antigen (CAT no: C30110)	5	C000099439, date: 14/07/2023	USD 380.00	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· Manufacturer is not registered. · No other registered sources.	Recommended only for this consignment. Advised to register the product.
12	25/08/2023	MD/1702/08/2023	Coccidioides IDTP ID Antigen	5	C000099439, date: 14/07/2023	USD 380.00	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· Manufacturer is not registered.	Recommended only for this consignment. Advised to register the product.
13	25/08/2023	MD/1703/08/2023	Cocci IDTP ID Positive Control	5	C000099439, date: 14/07/2023	USD 394.40	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· No other registered sources.	Recommended only for this consignment. Advised to register the product.
14	25/08/2023	MD/1704/08/2023	Histoplama ID Antigen	7	C000099439, date: 14/07/2023	USD 532.00	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· Manufacturer is not registered.	Recommended only for this consignment. Advised to register the product.
15	25/08/2023	MD/1705/08/2023	Histoplama ID Positive Control	6	C000099439, date: 14/07/2023	USD 473.28	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· No other registered sources.	Recommended only for this consignment. Advised to register the product.
16	25/08/2023	MD/1706/08/2023	Aspergillus ID Positive Control	3	C000099439, date: 14/07/2023	USD 236.64	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· Manufacturer is not registered.	Recommended only for this consignment. Advised to register the product.
17	25/08/2023	MD/1707/08/2023	Aspergillus ID Antigen	3	C000099439, date: 14/07/2023	USD 228.00	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· No other registered sources.	Recommended only for this consignment. Advised to register the product.
18	25/08/2023	MD/1708/08/2023	A. terreus ID Positive Control	4	C000099439, date: 14/07/2023	USD 315.52	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· Manufacturer is not registered.	Recommended only for this consignment. Advised to register the product.
19	25/08/2023	MD/1709/08/2023	Aspergillus terreus ID Antigen	4	C000099439, date: 14/07/2023	USD 304.00	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· No other registered sources.	Recommended only for this consignment. Advised to register the product.
20	25/08/2023	MD/1710/08/2023	Aspergillus niger ID Antigen	1	C000099439, date: 14/07/2023	USD 76.00	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· Manufacturer is not registered.	Recommended only for this consignment. Advised to register the product.
21	25/08/2023	MD/1711/08/2023	Aspergillus fumigatus ID Antigen	4	C000099439, date: 14/07/2023	USD 304.00	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· No other registered sources.	Recommended only for this consignment. Advised to register the product.
22	25/08/2023	MD/1712/08/2023	Aspergillus flavus ID Antigen	2	C000099439, date: 14/07/2023	USD 152.00	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· Manufacturer is not registered.	Recommended only for this consignment. Advised to register the product.
23	25/08/2023	MD/1713/08/2023	Candida ID Antigen	4	C000099439, date: 14/07/2023	USD 304.00	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· No other registered sources.	Recommended only for this consignment. Advised to register the product.
24	25/08/2023	MD/1714/08/2023	Candida ID Positive Control	2	C000099439, date: 14/07/2023	USD 157.76	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· Manufacturer is not registered.	Recommended only for this consignment. Advised to register the product.
25	25/08/2023	MD/1715/08/2023	Paracoccidiodes ID Antigen	5	C000099439, date: 14/07/2023	USD 380.00	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· Manufacturer is not registered.	Recommended only for this consignment. Advised to register the product.
26	25/08/2023	MD/1716/08/2023	Paracocci ID Postive Control	5	C000099439, date: 14/07/2023	USD 394.40	Microtech Biological (Pvt) Ltd	Immuno-Mycologics - United Status	For Medical Research Institute	· No other registered sources.	Recommended only for this consignment. Advised to register the product.
27	01/09/2023	MD/1725/09/2023	Nanopore Sequencing device, adapter and flow cells	As per the invoice	9007781, date: 28/07/2023	USD 7,826.99	Dr. A.D. De Silva, Biomedical Laborator 2, Faculty of Medicine, General Sir John Kotalawala Defence University	Oxford Nanopore Technologies - United Kingdom	For KDU	Research Purpose	Recommended only for this consignment.
28	14/07/2023	MD/1660/07/2023	Dental Equipments	As per the invoice	40951, date: 01/06/2023	$2,730.70	Dr. Diffna Leon	One Dental - Australia	For Educational Purpose	For Exam	Recommended only for this consignment.

Waiver of Registration Committee - Device 05/09/2023 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
01	15/08/2023	MD/1681/08/2023	Speaking Valve for tracheostomy tube with universal connection, Sterile	100 NOS	DHS/RS/RQ/251/896AK/21 , date: 21/06/2023 (SR No: 13200602)	US $ 1,200.00	Dilmark Medicare (Pvt) Ltd	Primed Halberstadt Medizintechnik GmbH - Germany	SPC Tender (MSD Order)	Manufacture registered with NMRA. No other valid registered sources available for speaking valve.	Recommended only for this consignment Subject to submission of dossier for registration.
02	15/08/2023	MD/1682/08/2023	SHAH GROMMENTS (Aural Grommet, Shah type or similar, size 1.0mm, sterile)	1700 NOS (1000 Nos - 3 Months from L/C, 700 Nos - 6 months after 1st lot)	DHS/RS/RQ/251/922AK/21, date: 20/07/2023 (SR No: 13200002)	US $ 55,539.00	Dilmark Medicare (Pvt) Ltd	Summit Medical LLC - USA	SPC Tender (MSD Order)	Manufacture is not registered with NMRA. No other valid registered sources available.	Recommended only for this consignment Subject to submission of dossier for registration.
03	15/08/2023	MD/1683/08/2023	Netcell Ear Wick 15mm (Ear Wick, Pope type or similar, sterile)	6900 NOS (5000 Nos - 30 months from L/C, 1800 Nos - 6 months after 1st lot	DHS/RS/RQ/251/922AK/21, date: 20/07/2023 (SR No: 13200501)	US $ 61,479.00	Dilmark Medicare (Pvt) Ltd	Network Medicals Products Limited - UK	SPC Tender (MSD Order)	Previously registered product with NMRA. (Ref: DVR/6438) Manufacturing site changed, but not applied for NMRA registration. No other registered sources.	Recommended only for this consignment Subject to submission of dossier for registration.
04	15/08/2023	MD/1684/08/2023	Netcell Nasal Pack 8cm (Nasal Tampon, straight, with draw string, 80mm lemgth, made of expandable surgical sponge, sterile	1800 NOS	DHS/RS/RQ/251/896AK/21 , date: 21/06/2023 (SR No: 13201600)	US $ 25,200.00	Dilmark Medicare (Pvt) Ltd	Network Medicals Products Limited - UK	SPC Tender (MSD Order)	· Previously registered product with NMRA. · (Ref: DVR-805-RR)	Recommended only for this consignment Subject to submission of dossier for registration.
05	08/06/2023	MD/1589/06/2023	Connector Double Swivel 360 degrees, with suction port	700	DHS/ICL/X/RSS/055/199NB/2022, date:12/05/2023	US $ 84,487.04	Medigrow International SS (Pvt) Ltd	Airways Surgical (Pvt) Ltd - India	SPC ICL Tender	· Manufacturer or Local Agent not registered. · ICL Product.	Recommended only for this consignment.
			Suction Tube, Peadiatric, baby yankeur type similar	10000
			Closed system suction catheter for ventikated patients, single use.	800
			Closed system suction catheter for ventikated patients, double use.	6000
06	01/09/2023	MD/1723/09/2023	Epidural & Plexus Anesthesia System	6250 NOS	LP/DHS/RS/RQ/228/920AK/21, date: 20/07/2023	LKR 24,500,000.00	Sunshine Healthcare Lanka (Pvt) ltd	Smith Medical ASD Inc - USA.	SPC Tender		Recommended only for this consignment. Advised to register the product.
07	01/09/2023	MD/1724/09/2023	Ring pressaries/Polythene/size 68mm external diameter/semi rigid/smooth finish/clinically clean	As per the invoice	DSH/S/WW/05/23, date: 07/02/2023	LKR 91,837,149.00	Sunshine Healthcare Lanka (Pvt) ltd	Cooper Surgical Inc - USA	SPC Tender		Recommended only for this consignment Subject to submission of dossier for registration.

Waiver of Registration Committee - Device 12/08/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
01	15/06/2023	MD/1612/06/2023	Used Toyota Ambulance (Nissan Elgrand Ambulance)	1	54231-0335, date: 08/5/2023	JPY 800,000	Olivia Hospital (Pvt) Ltd	Nissan Co. Japan - Japan	For Olivia Hospital	· Donation.	Recommended only for this consignment. Related medical devices should be evaluated by college of Aneasthesiologists.
02	23/06/2023	MD/1585/06/2023	VIVACE Electrosurgical Device	1	SHP230601SSA, date: 14/06/2023	USD 16,500.00	Silvacos (Pvt) Ltd	Shenb Co.ltd - Korea south	For a private skin clinic.	· Manufacturer or Local Agent not registered. Not applied for product registration.	Not recommended and advised to register the product.
03	15/06/2023	MD/1590/06/2023	Blood Collection Needle	50,000 Pcs	61230073, date: 17/05/2023	EUR 2,000,00	Ceylon Meditech Industries (Pvt) Ltd	Chirana T. Injecta - Slovak Republic		· Local agent has applied for the product registration (D-4616) and Pending heamotology evaluation. · Registered Sources Available (Needle for Vacuum blood collection tube)	Not recommended. Advised to Expedite the registration.
04	13/07/2023	MD/1641/07/2023	Endo GIA , Premium Plus CEEA	25	03-2-2023-COVIDIEN, date: 26/06/2023	USD 12,209.00	A. Baur & Co. (Pvt) Ltd	Covidien LLC - USA	For Kings Hospital - Colombo	· Local Agent has applied for product registration renewal. (D/4360 and D/4290)	Not recommended. Advised to Expedite the registration.
05	21/07/2023	MD/1661/07/2023	HomoSphere Advanced Monitoring Platform and List Components / Accessories	N/A	N/A	N/A	Meditechnology Holdings (Pvt) Ltd	Benchmark Electronics Inc - USA	For University Hospital - KDU and LRH Hospital (For Workshop)	· Manufacturer is registered. · Device for a Workshop to be done by the distributor and it will be returned back with the distributer once the workshop is over.	Recommended only for this consignment. To be re-exported after the workshop.
06	14/07/2023	MD/1659/07/2023	Spectra Optia Exchange Set / Spectra Optia IDL Set	936EA + 84EA	950093846, date: 10/07/2023	$132,600.00	Hemas Surgicals & Diagnostics (Pvt) Ltd	Terumo BCT Inc - USA	For National Blood Transfusion Services	· Previously WOR given on 09/05/2023. (WOR/DVR/195/2023) · The same NBTS Letters are attached with the Previous and New WOR requests. · SIL is approved · Product files not submitted to NMRA by Local Agent.	Recommended only for this consignment. (WOR for this consignment due to low stock level)
07	11/08/2023	MD/1670/08/2023	Human Kidney injury molecule 1, Kim-1-ELISA Kit, Human neutrophil gelatinase associated lipocalin, NGAL ELISA Kit	20 + 20	2023-0615-22-06, date: 19/06/2023	USD 12,600.00	Prof: P/Mangala C.S. De Silva, Department of Zoology, Faculty of Science, University of Ruhuna	Wuhan Humaei Biotech Co.Ltd - China	For Research Purpose	· Donation from Duke University - USA.	Recommended only for this consignment.
08	14/03/2023	MD/1453/03/2023	Life Signals Multiparameter Remote Monitoring System and Spare Parts Accessories (Brand:Biosensor , Model LX 1550)	50	01032023/HEMAS, date: 01/03/2023	$500.00	Hemas Surgical & Diagnostics (Pvt) ltd	Life Signals Inc - USA	For Testing and Examination Purposes.	· Submitted to WOR Committee held on 30/05/2023 and Decision was Pending decision. Instructed to submit reports for product with prior WOR approval. · Again Submitted to WOR Committee held on 15/06/2023 and Decision was Pending decision. No appeal request submitted.	Previously Discussed and document reviewing.

Waiver of Registration Committee - Device 12/08/2023 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
01	11/07/2023	MD/1639/07/2023	Soft Cloth Liner Tape	21,489	LP/DHS/RS/EP/67/548KC/2022, date: 27/06/2023	LKR 10,467,077.01	Shaka Holdings (Pvt) Ltd	Jinhua jingdi Medical Supplies Co.Ltd - China	SPC Tender	· Registered Manufacture with Rokem Pharmaceuticals. No active registrations available. · Local Agent is not registered with NMRA. · Other valid registered sources available. · Previously WOR given by CEO Minute. (Dated on 09/03/2023, (WOR/DVR/134/2023))	Not recommended and advised to register the product. (Decision as per previous consignment)
02	13/07/2023	MD/1644/07/2023	Root Canal Sealer , Resin Based, for permanant filling of root canal	4200	LP/DHS/S/WW/237/900KP/21, date: 29/06/2023		Ogaki & Company	Shiva Products - India	SPC Tender	· Manufacturer registered with LW Medicals. All the other products were Agency Transferred to Ogaki & Company. · Other registered sources are available. · Not applied for product registration.	Not recommended and advised to register the product.
03	11/07/2023	MD/1638/07/2023	Hearing aid and standard accessories	17500	LP/DHS/M/S/WW/12/874MT/21, date: 02/05/2023	LKR 790,125,000.00	D.S. Jayasinghe Optician (Pvt) Ltd	Sivantos GmbH - Germany	SPC Tender	· Previously registered product (D/183) and site has been changed. · FSC is still being processed in the country of origin.	Recommended only for this consignment. Advised to register the new site.
04	21/07/2023	MD/1662/07/2023	Rib Shear (Reusable Instruments)	02 Nos	DHS/SUS/WW/190/581DR/2021, date: 26/08/2022 (SR No: 21802701)	EUR 1545.60	B. Braun Lanka (Pvt) Ltd	Aesculap AG - Germany	SPC Tender	· Manufacturer and Local Agent registered. · No other registered sources available.	Recommended only for this consignment.
05	13/07/2023	MD/1643/07/2023	Soft Cloth Liner Tape (Non-Women Fixing Tape)	70,000	LP/DHS/RS/EP/2/28KC/2023, date: 26/06/2023 , LP/DHS/RS/EP/3/30KC/2023, date: 26/06/2023	LKR 7,623,000.00 + LKR 18,364,500.00	Medica Pharmaceuticals (Pvt) Ltd	Zheijiang Kekang Medical Technology Co.Ltd - China	SPC Tender	· Two other valid registered sources are available. · Manufacturer is not registered. · Local Agent is not registered.	Not recommended and advised to register the product.
06	14/03/2023	MD/1454/03/2023	C Reactive Protein Latex Agglutination 100 Tests/Kit	1000	DHS/ICL/X/RL/031/25SM/22, date: 28/10/2022	US$ 7,500.00	Elshaddai Enterprises (Pvt) ltd	Genuine Biosystem (Pvt) ltd - India	SPC ICL	· Manufacture is registered. But No active registrations available. · Local Agent is registered. · Registered sources available.	Not recommended by college of chemical pathologists.
07	10/03/2023	MD/1450/03/2023	Orthodontic Wires and Brackets	As per the indent	DHS/ICL/X/RSS/060/163RD/2022, date: 19/01/2023	As per the indent	Demed (Pvt) ltd	Modern Orthodontics - India	SPC ICL	· Manufacturer is not registered. · Local Agent is registered.	Recommended only for this consignment. Advised to submit the dossier for registration.
08	10/03/2023	MD/1451/03/2023	Orthodontic Wires	As per the indent	DHS/ICL/RSS/064/165RD/22, date: 25/01/2023	As per the indent	Demed (Pvt) ltd	Modern Orthodontics - India	SPC ICL	· Manufacturer is not registered. · Local Agent is registered.	Recommended only for this consignment. Advised to submit the dossier for registration.

Waiver of Registration Committee - Device 15/07/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
01	22/06/2023	MD/1613/06/2023	HLA Reagents and consumables	As per the invoice	8222118, date: 12/06/2023	USD 5,338.18	Emar Pharma (Pvt) Ltd	One Lambda Inc - USA	For National Blood Transfusion Service	Previously given WOR. (WOR/DVR/316 , WOR/DVR/69) Manufacturer is registered with NMRA. No other registered sources.	Recommended only for this consignment. Advised to initiate product registration.
02	22/06/2023	MD/1619/06/2023	DNA Whole Blood Kit (Brand: MagCore Genomic)	46	EP/RBC/02-2023, date: 12/06/2023	$3,766.00	Emar Pharma (Pvt) Ltd	RBC Bioscience Corp. - Taiwan	For National Blood Transfusion Service	Manufacturer is not registered with NMRA.	Recommended only for this consignment. Suggested to initiate product registration.
03	31/05/2023	MD/1578/06/2023	OPPO non-active orthopedic appliance	As per the invoice	OP01-202303009, date: 16/03/2023	USD 74,655.79	Hemas Surgical & Diagnostics (Pvt) Ltd	OPPO Medical Corporation - Taiwan	For Manufacturing Site Change	Previously given WOR. (15/12/2022, WOR/DVR/483/2022) Site is registered with NMRA for this local agent.	Not recommended. Advised to expedite the registration.
04	31/05/2023	MD/1579/06/2023	OPPO non-active orthopedic appliance	As per the invoice	OP01-202303008, date: 16/03/2023	USD 262,370.53	Hemas Surgical & Diagnostics (Pvt) Ltd	OPPO Medical Corporation - Taiwan	For Manufacturing Site Change	Previously given WOR. (15/12/2022, WOR/DVR/484/2022) Site is registered with NMRA for this local agent.	Not recommended. Advised to expedite the registration.
05	30/06/2023	MD/1628/07/2023	Reagents for Hematology Analyzer	As per the invoice	10040645, date: 07/06/2023 , 10040646, date: 14/06/2023	USD 34,885.00 + USD 2,470.00	Hemas Surgicals & Diagnostics (Pvt) Ltd	Nihon Kohden - Japan	For Sri Lanka Air Force and Department of Health Services-Northwesstern Province.	Manufacturing site is registered with NMRA. No other registered sources for Nihon Kohden hematology reagents.	Recommended only for this consignment.
06	22/06/2023	MD/1616/06/2023	Mizuho Vascular Doppler System	9	PI23-066, date: 05/06/2023	USD 14,368.00	Medapp (Pvt) Ltd	Vascular Technology Inc - USA	For Vascular Neuro Surgeries. (Dr. Sunil Perera, Consultant Neurosurgeon, Central Hospital (Pvt) Ltd)	Manufacturer is registered under NMRA with another local agent. One registered source available.	Not recommended and advised to register the product.
07	22/06/2023	MD/1615/06/2023	Video Endoscopy System with Accessories and Spare Parts	As per the invoice	PMSSPI20872/89, 30/5/2023	USD 23,038.94	Biomed (Pvt) Ltd	Hoya Corporation - Japan	For Several government hospital	Addition of items to the existing accessory list can be done.	Advised to follow the variation process.
08	22/06/2023	MD/1617/06/2023	Transport Cooler (Brand: Haier, Model: BCD115)	1	HRP-003-BIOMEDICA-2023, date: 16/06/2023	USD 395.00	Biomedica (Pvt) Ltd	Haier Biomedical Co.ltd - China		Manufacturer is currently not registered at NMRA.	Not recommended and advised to register the product.
09	13/06/2023	MD/1589/06/2023	Face Mask ASTMD 5034/ASTMD 2261	200	IE6604000016, date: 25/04/2023	USD 200.00	Ansell Lanka (Pvt) Ltd	Prudential Ampri (Thailand) Co.ltd - Thailand	For ISO 4 standard clean room operational works.	Manufacturer is not registered with NMRA.	Advised to apply for product categorization.
10	07/07/2023	MD/1640/07/2023	Microtome Blade	2	9999052424 date: 21/06/2023	EUR 128.02	Analytical Instruments	Richard-Allan Scientific LLc - USA	For Army Medical Procurement Services	Manufacturer is registered.	Not recommended and advised to register the product.
11	30/06/2023	MD/1627/07/2023	iTero Element CPO Flex intra oral scanner	01	Invoice date: 05/06/2023	INR 999,999.00	Dr. K. Paranthamalingam	Zheijiang Kekang Medical Technology Co.Ltd - China	For private orthodontic clinic.		Not recommended and advised to register the product.
12	07/07/2023	MD/1645/07/2023	Portable Stretcher	500	SHS-23107, date: 26/06/2023	US $ 15,000.00	Korean Lanka Holding	Suzhou Highsee Medical Co.Ltd - China	For Sri Lanka Railways		Recommended only for this consignment.
13	07/07/2023	MD/1648/07/2023	Emergency Bandages and Sam Splint	As per the invoice	30569, date: 11/10/2023, 9000043731, date: 2510/2022	985.14	The HALO Trust	Ferton Pharmaceuticals Ltd – London SP Services (UK) Ltd	For National Mine Action Centre (NMAC)		Recommended only for this consignment.
14	11/07/2023	MD/1649/07/2023	Cysto-nephro Fiberscope	2	5092640, date: 06/07/2023	SDG 19,630	Technomedics International	Olympus Medical System Cor- Japan	For University of Sri Jayawardenepura	Previously registered product with NMRA and expired.	Recommended only for this consignment. Advised to expedite registration.
15	11/07/2023	MD/1650/07/2023	Pharmacy Refrigerator	1	HRP-004-BIOMEDICA-2023, date: 06/07/2023	USD 780.00	Biomedica (Pvt) Ltd	Haier Biomedical Co.Ltd - China	For District General Hospital - Galle	One registered source available.	Not recommended and advised to register the product.
16	23/05/2023	MD/1560/05/2023	Wallace Catheters & Oocyte Recovery Set	420	OIPL/23-24/PI/AB/001, date: 27/04/2023	$29,652.00	A. Baur & Co. (Pvt) ltd	Cooper Surgical Inc - USA	For Several Private Hospitals in Sri Lanka	Submitted to WOR Committee held on 30/05/2023 and Decision was Not recommended and advised to register the product. (Manufacture registered with another local agent.)	Not recommended. Manufacturer registered with another local agent. Advised to complete the market authorization transfer process.
17	25/05/2023	MD/1572/05/2023	Semi-Automated Coagulometer with Accessories Consumables, Controls & Re-agents (C-Series)	1 + 1	3420/0012216	$1,812.72	Analytical Instruments (Pvt) Ltd	Helena Biosciences Europe - UK	For Premium International (Pvt) Ltd (For New Maternity Hospital - Galle)	Submitted to WOR Committee held on 20/06/2023 and Decision was Pending Decision. Advised to apply for renewal of registration. Previously registered product with NMRA. Existing registered is expired. Registered sources available for different brands.	Will give consignment clearance when the product file is submitted. Advised to expedite the registration.
18	14/03/2023	MD/1453/03/2023	Life Signals Multiparameter Remote Monitoring System and Spare Parts Accessories (Brand:Biosensor , Model LX 1550)	50	01032023/HEMAS, date: 01/03/2023	$500.00	Hemas Surgical & Diagnostics (Pvt) ltd	Life Signals Inc - USA	For Testing and Examination Purposes.	Submitted to WOR Committee held on 30/05/2023 and Decision was Pending decision. Instructed to submit reports for product with prior WOR approval.	Pending decision. No appeal request submitted.
19	01/06/2023	MD/1580/06/2023	Investment Materials, Expansion Liquid, Plaster Paris Hard, Casting Ring Liners, Duplicating Gel, Silicone, Waxes-Paraffin, Light Cure Acrylic for Customs Impression Crown, Bridge Acrylic.	As per the invoice	230676, date: 05/04/2023	EUR 1,752.93	Geston Lanka (Pvt) Ltd	Mega dental GmbH - Germany	For external use in dental laboratories.	Submitted to WOR Committee held on 20/06/2023 and Decision was Pending Decision. Advised to submit a product catalogue for the NMRA registered products. Previously registered few products from a registered manufacturer. (Expired)	Advised to apply for Product Categorization.

Waiver of Registration Committee - Device 15/07/2023 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
1	09/01/2023		Bacterial and Viral Filter Paediatric , Incentive Spirometer for Paediatric, disposible	18,000 + 6,000	DHS/ICL/X/RS/053/340AK/22, date: 17/10/2022	US $ 53,160.00	Medigrow International SS (Pvt) ltd	J.K Medical Systems (Pvt) ltd - India	SPC ICL Procurement	Manufacturer not registered with NMRA.	Recommended only for this consignment of Spirometers. Bacterial and Viral Filter Paediatric should be sent to college of Microbiologists.
2	09/01/2023		Incentive Spirometer fo Adult, disposible	58,000	DHS/ICL/X/RS/053/362AK/22, date: 25/10/2022	US $ 181,540.00	Medigrow International SS (Pvt) ltd	J.K Medical Systems (Pvt) ltd - India	SPC ICL Procurement	Manufacturer not registered with NMRA.	Recommended only for this consignment.

Waiver of Registration Committee - Device 20/06/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
1	25/04/2023	MD/1516/05/2023	CAP Samples	6	448503-1, date: 31/10/2023	$3,049.00	Stemz Healthcare Lanka	College of American Pathologists - USA	For CAP Programme	No registered sources at present.	Recommended only for this consignment.
2	25/05/2023	MD/1572/05/2023	Semi-Automated Coagulometer with Accessories Consumables, Controls & Re-agents (C-Series)	1 + 1	3420/0012216	$1,812.72	Analytical Instruments (Pvt) Ltd	Helena Biosciences Europe - UK	For Premium International (Pvt) Ltd (For New Maternity Hospital - Galle)	Previously registered product with NMRA. Existing registered is expired. Registered sources available for different brands.	Pending Decision. Advised to apply for renewal of registration.
3	23/05/2023	MD/1564/05/2023	Vigor Peek Disc Spacer (O), Polyaxial Screw, Smooth Rod, Hex Set Screw	817	ASD6-2212000007, ASD6-2304000009, date: 24/04/2023	28,490.00	Spine Care (pvt) ltd	A-Spine Asia Co.ltd - Taiwan	Site Location Change	Product is registered. Due to the manufacturing site change, the new location should be registered.	Not recommended and advised to register the product.
4	29/05/2023	MD/1577/05/2023	Plaster of Paris Bandage	1,008	JX230318, date: 18/03/2023	$644.11	Nirutha Packaging (Pvt) Ltd	Anji Hongde Medical Product Co.Ltd - China	For release the consignment	Manufacturer is not registered with NMRA. Other registered sources are available.	Not recommended and advised to register the product.
5	01/06/2023	MD/1580/06/2023	Investment Materials, Expansion Liquid, Plaster Paris Hard, Casting Ring Liners, Duplicating Gel, Silicone, Waxes-Paraffin, Light Cure Acrylic for Customs Impression Crown, Bridge Acrylic.	As per the invoice	230676, date: 05/04/2023	EUR 1,752.93	Geston Lanka (Pvt) Ltd	Mega dental GmbH - Germany	For external use in dental laboratories.	Previously registered few products from a registered manufacturer. (Expired)	Pending Decision. Advised to submit a product catalogue for the NMEA registered products.
6	15/06/2023	MD/1591/06/2023	FDG F-18 (Flurodeoxyglucose 18F)	60 LOT (6000 Nos)	MARK/PI/1/23-24, date: 19/06/2023	USD 108,000	Markss HLC (PVT) Ltd	Shreeji Imaging & Diagnostic Centure Pvt Ltd - India	For Apeksha Hospital - Maharagama	Not registered sources for FDG F - 18. Manufacturer is not registered.	Not recommended and advised to register the product. (Already registered product of Siemns with Dimo (Pvt) Ltd. FDG F-18 should come under Atomic Energy Authority approval.)
7	16/06/2023	MD/1592/06/2023	Medtronic Spine (Brand: Medtronic)	As per the invoice	MKT_052023_SG-LK, date: 05/06/2023	USD 231,439.07	A. Baur & Co. (Pvt) Ltd	Medronic Inc - USA	For The Sri Lanka Orthopedic AssociationWorkshop Programme (Re-export basis)	Manufacturer is registered.	Recommended only for this consignment.

Waiver of Registration Committee - Device 20/06/2023 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
1	28/04/2023	MD/1522/05/2023	Drill Wire Kishner type or similar, both ends trocar pointed	As per the indent	DHS/S/WW/40/290VW/22, date: 07/10/2022	US $ 6,293.00	Excel Agency	M/S Siora Surgical (Pvt) ltd - India	SPC Tender (Process Under the Indian Credit Line Facility)	Manufacturer & the product is previously registered. (Expired) Other registered sources are available.	Recommended only for this consignment.
2	21/04/2023	MD/1510/04/2023	Oxygen Masks / Hudson Mask with tubing for adult	150,000 NOS	LP/DHS/RS/EP/61/486AK/22, date: 06/04/2023	LKR 41,250,000.00	Sethmedi International (Pvt) ltd	Guangdong Ecan Medical Co.ltd - China	SPC Tender	Submitted to WOR Committee held on 30/05/2023 and Decision was Not recommended and advised to register the product. Advised to submit the samples for end-user evaluation. (College of Anesthesiologists.)	Not recommended and advised to register the product. Advised to purchase from registered sources available for the product.

Waiver of Registration Committee - Device (January 2023 to May 2023)

Waiver of Registration Committee - Medical Device (January 2023 to May 2023)

06/01/2023

Date of Submission

NMRA Ref: Number

Item

Qty

Invoice / Tender Number

Invoice Value

Applicant

Manufacturer/ Supplier

Reason for WOR

Remarks

WOR Committee Approval

21/11/2022

MD/1224/11/2022

Elastic Adhesive Bandage

30000 Pcs

IMC/2022-23/554, date: 15/11/2022

USD 25,700.00

Sisili Projects Consortium (Pvt) ltd

Imperial Medicare (Pvt) ltd - India

For State Pharmaceuticals Corporation

Manufacturer is registered. Registered Source available. Sample license applied on November 2022.

Not recommended. Expedite the registration.

21/11/2022

MD/1225/11/2022

Folding Stretchers

130

SHS-22187, date: 19/10/2022

US $ 3,900.00

Cooper International

Suzhou Highsee Medical Co.ltd - China

For Sri Lanka Railways

Manufacture is not registered. Registered source available. Purchasing from unregistered source.

Not recommended and advised to re-export.

21/11/2022

MD/1226/11/2022

Autoclave Machine with Standard Accessories and Spare Parts (Eschmann - Autoclave Machine) (Brand: Eschmann)

18096, date: 07/11/2022

E 1,052.40

Mediquipment Limited

Wschmann Technologies Ltd - UK

For Asiri Surgical Hospital

Manufacturer is registered.

Recommended only for this consignment.

28/11/2022

MD/1233/11/2022

Automatic Blood Component Extractor and Standard Accessories (Brand: Delcon, Model: Gioto-Monza)

N/A

LKR 13,366.093.00

A.J. Medichem International (Pvt) ltd

Delcon SRL - Italy

For General Sir John Kotelawala Defence University Hospital

Manufacturer is registered. Registered sources available. (Ceyoka and Hemas)

Not recommended. Expedite the registration.

23/11/2022

MD/1235/12/2022

2% Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP/BP (Brand: Optagel)

132000

14/POP/ABCPSL/07/2022-23, date: 10/11/2022

USD 18,000.00

ABC Pharma Services (Pvt) ltd

Popular Phrmaceuticals (Pvt) ltd - Bangaladesh

Manufacturer is registered.

(Registered Sources available.)

Recommended only for this consignment.

30/11/2022

MD/1236/12/2022

Sterilizer - Sterilizer System and Spare Parts, Standard Accessories (Getinge HS 66 Hospital Sterilizer) (Brand: Getinge, Model: HS Series)

8085412708, date: 23/11/2022

USD 2432.86

Mediquipment Limited

Getinge AB - Sweden

For Lanka Hospital

Recommended only for this consignment.

30/11/2022

MD/1237/12/2022

Ion Plus Efragment Kit, Seqstudio Cathode Buffer Container, Seqstudio Cartridge V2, Ion Ampliseq Library Kit Plus, Genescan 600 LIZ dye Size Standard v2.0, Ion 540 Kit-OT2, Ion SingleSeq 96 Kit LUN, AmpFLSTR Identifiler Plus PCR Amplification Kit

As per the invoice

73942051 SO, date: 22/11/2022

USD 20,722.00

Genelabs Medical (Pvt) ltd

Life Technologies Holdings (Pte) Ltd - Singapore

For Research Purpose

Recommended only for this consignment.

16/12/2022

MD/1267/12/2022

HLA Reagents

87 + 42

7883657, date: 12/02/2022, 7883707, date: 12/02/2022

USD 116,946.92 + USD 12,578.70

Emar Pharma (Pvt) ltd

One Lambda Inc - USA

For Nationaal Blood Transfusion Service

Already issued by CEO Minute.

CEO Decision.

13/12/2022

MD/1268/12/2022

Glucose Meter, Test strips, Blood Lancets

600 + 6000+ 12000

SL-90197-20221130, date: 30/11/2022

$ 29.920.00

Medica Pharmaceuticals (Pvt) ltd

Visgeneer Inc - Taiwan

Out of Stock situation in the health sector

Not recommended and advised to register the product.

13/12/2022

MD/1269/12/2022

Amies Agar Gel + Charcoal (Single), Puritan HydraFlock 6" Sterile Mini-tip Flock Swab w/Polystyrene Handle, Parafild, SSIbio 2ml standing screw tubes, Axgen 1.5 ml microcentrifuge tubes, Disposable Wireloops

500 + 500 + 2 rolls + 2000 + 2000 + 2000

Date : 14/11/2022

HK $ 9,939.62

Veranja Liyanapathirna, Department of Microbiology, Faculty of Medicine, University of Peradeniya

Department of Microbiology - Hong Kong

For Research Purpose

Subject to submission of Ethic Review Committee Approval.

15/12/2022

MD/1270/12/2022

Laparoscopy System with St Accessories Spare Parts

As per the invoice

00034676, date: 06/12/2022

SGD 116,061.54

Technomedics International (Pvt) ltd

Olympus Medical Systems Corp - Japan

Recommended only for this consignment and expedite the registration.

19/12/2022

MD/1277/12/2022

Automated External Defibrillator and Spare Parts

10034184, date: 15/12/2022

USD 4,165.98

Hemas Surgical & Diagnostics (Pvt) ltd

Nihon Kohden - Japan

For Colombo International Container Terminals Limited.

Not recommended. Expedite the registration.

21/12/2022

MD/1278/12/2022

Interacoustics Titan-DPOAE440

PO NO: PO58539, date: 23/11/2022

Rs. 3,080,000.00

J.M. Wickramarachchi & Company (Pvt) ltd

Interacoustics A/S - Denmark

For Ninewells Hospital (Pvt) ltd

Recommended only for this consignment. Expedite product registration process.

21/12/2022

MD/1281/12/2022

Sterilizer - Sterilizer System and Spare Parts, Standard Accessories (Getinge HS 66 Hospital Sterilizer) (Brand: Getinge, Model: HS Series)

As Per the invoice

8085412847, date: 15/12/2022

USD 7,235.24

Mediquipment Limited

Getinge AB - Sweden

For Wathupitiwala Base Hospital

Recommended only for this consignment.

15/12/2022

MD/I283/12/2022

College of American Pathologist (CAP) Proficiency Testing Program

As Per the invoice

432115 (CAP Number: 902147901) , date: 05/12/2022

$73,745.00

Lanka Hospital Diagnostics (Pvt) ltd

College of American Pathologist - United States of America

For CAP Programme

Recommended only for this consignment.

27/12/2022

MD/1291/01/2023

Syringe, IV Set with Air vent, IV Cannula (Brand: Hi-Teck)

1,085,500

PI/HM/2022-23/078, date: 21/11/2022

$37,539.50

Medica Pharmaceuticals (Pvt) ltd

Hi-Teck Medics (Pvt) ltd - India

For Government Hospitals.

Not recommended and advised to register the product.

27/12/2022

MD/1292/01/2023

Cysto-nephro Fiberscope (Brand: Olympus, Model: CYF-5A)

RSI-FY2023-189R, date: 19/12/2022

SGD 8,077.12

Technomedics International (Pvt) ltd

Olympus Medical Systems Corp - Japan

For Clear the Shipment

Not recommended. Expedite the registration.

29/12/2022

MD/1294/01/2023

Medical Items

As per the invoice

00034780, date: 14/12/2022

SGD 301,959.00

Technomedics International (Pvt) ltd

Olympus Medical Systems Corp - Japan

For Clear the Shipment

Not recommended and advised to register the product.

23/12/2022

MD/1301/01/2023

Medical Items

As per the invoice

00034783, date: 14/12/2022

SGD 296,054.88

Technomedics International (Pvt) ltd

Olympus Medical Systems Corp - Japan

For Clear the Shipment

Not recommended and advised to register the product.

28/12/2022

MD/1302/01/2023

Colostomy Bags

10000

221223, date: 23/12/2022

$8,420.00

Medica Pharmaceuticals (Pvt) ltd

Whuhan Sitaili Medical Apparatus Development Co.ltd - china

Above Health System Enhancement project

Not recommended and advised to register the product.

07/09/2022

MD/1062/09/2022

Dental Extraction Elevators

S20220608, date:08/09/2022 (DE 532)

USD$ 55.90

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

Not registered Manufacturer.

Submitted to WOR Committee held on 08/10/2022 and Decision was

Pending Decision.

Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied.

Not recommended. Advised to purchase from local supplier.

07/09/2022

MD/1063/09/2022

Autoclave Sterilizer

S20220608, date:08/09/2022

USD$ 480.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

07/09/2022

MD/1064/09/2022

Complete Dental Chair and Unit + Air Compressure

S20220608, date:08/09/2022

USD$ 4,730.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

07/09/2022

MD/1065/09/2022

Physio Dispensor

S20220608, date:08/09/2022 (C-SAILOR)

USD $ 1,700.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

07/09/2022

MD/1066/09/2022

Dental Light Luring Metchine

S20220608, date:08/09/2022 (LED-B)

USD$ 53.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

07/09/2022

MD/1067/09/2022

SCS Extraction Forceps

S20220608, date:08/09/2022 (DE-255)

USD $ 50.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

07/09/2022

MD/1068/09/2022

Dental Extraction Froceps

S20220608, date:08/09/2022 (DE-256)

USD $ 80.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

07/09/2022

MD/1069/09/2022

Dental Extraction Froceps

S20220608, date:08/09/2022 (DE-254)

USD $ 75.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

07/09/2022

MD/1070/09/2022

Dental Extraction Froceps

S20220608, date:08/09/2022 (DE-253

USD $ 97.50

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

07/09/2022

MD/1071/09/2022

PCS CRP rapid test kit, PCS FTN test Kits, PCS CTN test kits, PCS CRP test detection buffer

8+2+3+8

N/A

A.A. Jeyapragasam

M/s. Guangzhou Wondfo Biotech Co.ltd - China

For Abishaa Hospital (Pvt) ltd - Vavuniya

Manufacturer is registered under NMRA with, Lifeserv – HCG Strips.

- PC Pharma - Syphilis test.

- Sri Chin Holdings – HCG Strip.

Submitted to WOR Committee held on 08/10/2022 and Decision was Not recommended and advised to register the product.

Not Recommended. Expedite the registration.

06/01/2023 - S.P.C

Date of Submission

NMRA Ref: Number

Item

Qty

Invoice / Tender Number

Invoice Value

Applicant

Manufacturer/ Supplier

Reason for WOR

Remarks

WOR Committee Approval

23/11/2022

MD/1228/11/2022

Eye Speculum 80mm (Article no: OA225R) (Brand: Aesculap)

394979525, date: 31/10/2022

EUR 1,265.00

B. Braun Lanka (Pvt) ltd

Aesculap AG - Germany

For SPC (Not attached SPC Indent)

Manufacturer registered with NMRA. No registered sources as per the NMRA database.

Recommended only for this consignment. Advised to submit a SPC indent.

05/12/2022

MD/1244/12/2022

Blood Lancet (Brand: Paramount)

315,000 NOS

LP/DHS/RL/EP/12/60WAC/22, date: 25/11/2022

LKR 1,827,000.00

Medica Pharmaceuticals (Pvt) ltd

Paramount Surgimed Limited - India

SPC Tender

Manufacturer registered with Premium Healthcare up to 2019.

Not recommended and advised to register the product.

21/12/2022

MD/1279/12/2022

Cardiac Troponin I qualitative Strips

7600 Strips

LP/DHS/RL/EP/11/64SR/2022, date: 02/12/2022

LKR 3,724,000.00

Elshaddai Enterprises (Pvt) ltd

Accurex INC - India.

SPC Tender

Manufacturer site registration has completed.

Pending Decision. Advised SPC to submit tender documents and details of evaluation.

21/12/2022

MD/1282/12/2022

ECG Recording Papers

25 Pack + 1000 Roll

LP/DHS/RL/EP/32/55SSN/2022, date: 11/11/2022

LKR 1,109,432.89

Biomedica (Pvt) ltd

CMICS Medical Instruments Co.ltd - China

SPC Tender

Manufacturer is not registered. Not applied for registration yet.

Pending Decision. Advised SPC to submit tender documents and details of evaluation.

29/12/2022

MD/1293/01/2023

Immunohistochemistry Reagents (Brand: Dako Agilent)

119

DHS/RL/33/25SM/21, date: 14/10/2022

US $ 73,538.88

A & M Suhada Enterprises (Pvt) ltd

Agilent Technologies Singapore (International) Pte Ltd - Singapore

SPC Tender

Manufacturer is registered with NMRA.

Pending Decision. Advised SPC to submit tender documents and details of evaluation.

25/10/2022

MD/1176/10/2022 (MD/1135/10/2022)

Pacing Lead (Brand: Medtronic, Model: 5076) , Rercutaneous Lead Introducer (Brand: Medronic, Model: 6207)

900 NOS

DHS/M/SS/WW/4/565DP/2021, date: 12/07/2022

US $ 562,500.00

Medrac (Pvt) ltd

Medtronic Inc - USA

SPC Tender

Registered manufacturer site with Medtrac (Pvt) ltd. (SIL 4785/01/2022)

Submitted to WOR Committee held on 08/10/2022 and Decision was

Pending. Advised to request the registration certificate include the accessories.

Submitted to WOR Committee held on 19/11/2022 Not recommended. Expedite the registration. Advised to request the registration certificate include the accessories.

Submitted to WOR Committee

CEO Decision.

25/10/2022

MD/1177/10/2022 (MD/1136/10/2022)

Rercutaneous Lead Introducer (Brand: Medtronic, Model: 6207, 6209) , Facing Lead (Brand: Medtronic, Model: 5076, 6935M)

720 NOS

DHS/M/SS/WW/5/573DP/2021, date: 22/07/2022

US $ 1,134,000.00

Medrac (Pvt) ltd

Medtronic Inc - USA

SPC Tender

Registered with Medtrac (Pvt) ltd for "Vitatron MRI Surescan" single chamber pacemaker. (Ref:D-3388) (SIL under processing)

CEO Decision.

11/02/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Approval
1	09/01/2023	MD/1367/01/2023	Surgical Drapes and Gowns	490	PI/2212301, date: 30/12/2022	USD 2,252.00	Zodiac Medicals (Pvt) ltd	Careon Healthcare Solutions (Pvt) ltd - India	For Patient and orthepedic surgeons	NMRA registration under processing. (File Number: D/4384) Registered Manufacturer. Registered source available.	Not recommended and advised to register the product.
2	09/01/2023	MD/1368/01/2023	EEA Auto Suture, V Loc 180, Endo GIA	As per the invoice	6208941373, date: 05/12/2023	USD 6566.09	A. Baurs & Co. (Pvt) ltd	Covidien LLC - USA	For Government and Private Hospitals		Recommended only for this consignment. Advised to submit registration documents for EEA Auto Suture.
3	18/01/2023	MD/1370/01/2023	Hep G2 Cell Line Human	1	8206222076, date: 23/08/2022	Eur 610.00	Dr. S.K.M.K. Herapathdeniya, University of Colombo, Institute of Indigenous Medicine.	Sigma Aldrich, United Status	For Research Purpose		Recommended only for this consignment.
4	13/01/2023	MD/1371/01/2023	Liquid Based Cytology Machine with GYN Trans Cyt Filters (Clear), Thinprep slide kit GYN Asian	1	6508830, date: 05/01/2023	20000	Next-Vantage (Pvt) ltd	Hologic Asia Pacific Limited - Hong Kong	For Family Health Bureau		Recommended only for this consignment.
5	18/01/2023	MD/1373/01/2023	Intraoperative Bags (Brand : Dual Drawstring Bags)	5	00074404, date:07/08/2022	$525.00	Apcot Marketing (Pvt) ltd	Southern Cross Hospital Supplies - Australia	For National Blood Transfusion Service		Recommended only for this consignment.
6	20/01/2023	MD/1374/01/2023	Automated External Defibrillator and Spare Parts	6	10034184, date: 15/12/2022	USD 4165.98	Hemas Surgical & Diagnostics	Nihon Kohden - Japan	For Colombo International Container Terminals Limited.		Recommended with condition. WOR granted for only spare parts. Dossier to be submitted for the defibrillator for registration.
7	30/01/2023	MD/1376/01/2023	Hoya Intraocular Lens - Fortable	1900	VSPI203790, date: 28/12/2022	USD 83925	Vision Solutions Lanka (Pvt) ltd	Hoya Medical Singapore Pte. Ltd - Singapore			Not recommended and advised to register the product.
8	27/01/2023	MD/1378/01/2023	Blood and infusion warmer with / without Tube Flow and consumables (BW 685 blood & infusion warmer and extention set	6	SO20232569, date: 16/01/2023	Euro 4,851.00	Emar Pharma (Pvt) ltd	Biegler GmbH - Austria	For Development of Kalutara Specialized Women & Children's Hospital.		Recommended only for this consignment.
9	08/02/2023	MD/1399/02/2023	Solberg Filter Cartridge, Expulsion Filter SV-CEG915-NW25/050HCB, OIL for Vaccume Pump AV-30 Container, 1220x610x69 LPD+LV+2GASKETS H14 Filter, Absolute Filter Hepa 610x457x69mm	As per the invoice	1120503, dated: 13/12/2022	1624.52	Institute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo	Azbil Telstar TEchnologies SLU - Spain	For Research and Development Purpose		Recommended only for this consignment.
10	08/02/2023	MD/1400/02/2023	NTERA-2 cl.D1; Embryonal Carcinoma; Human (Homo Sapiens)	1	SQ023275, date:02/01/2023	USD 1,199.85	Institute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo	American Type Culture Collection (ATTC) - USA	For Research and Development Purpose		Recommended only for this consignment.
11	16/01/2023	MD/1369/01/2023	EEG Scanner	1	460162, date : 31/10/2022	USD 2,318.95	Quantine Technologies (Pvt) ltd	-	Research Purpose.		Pending Decision. Request to provide research proposal ethical clearance.
12	08/02/2023	MD/1406/02/2023	Syringe Insulin 1ml/40IUw/Needle, 30Gx0.5", Pack of 12 Pieces.	25	237007330, date: 27/01/2023	USD 2061.50	National STD/AIDS Control Programme	Becton Dickinson International - Belgium	Donation to STD/AIDS Control programme.		Recommended only for this consignment.
13	08/02/2023	MD/1407/02/2023	Determine HIV Early Detect Set 100T & Determine HIV ½ Serum/Plasma 100 Test/K.	25	237007330, date: 27/01/2023	USD 2061.50	National STD/AIDS Control Programme	Abbott Diagnostics Medical Co.ltd - Ireland.	Donation to STD/AIDS Control programme.		Recommended only for this consignment.

11/02/2023 - S.P.C
1	18/01/2023	MD/1372/01/2023	Soft Cloth Liner tape	28,398	LP/DHS/RS/EP/67434KC/2022, date: 11/01/2023	LKR 18444424.95	Shaka Holdings (Pvt) ltd	Jinhua Jingdi Medical Supplies Co.ltd - China	SPC Tender	Manufacturer registered with another local agent (Rokem Pharmaceuticals) for Sink oxide surgical plaster in 2014. Registered source available. 3M Lanka (Sunshine), Shimmers. Valid registration.	Not recommended and advised to register the product.
2	27/01/2023	MD/1375/01/2023	Laboratory Consumables	16	DHS/RL/98/28SSN/2021, date: 15/12/2022	US $ 10,443.00	State Pharmaceuticals Corporation of Sri Lanka	M/s. Agilent Technologies Sigapore (Sales) Pte. Ltd - Singapore	SPC Tender	Manufacturer (M/s. Agilent Technologies - USA, M/s. Agilent Technologies - Denmark) registered with this local agent recently. (FMSA/MD/2021/71)	Recommended with condition. Subject to summation of dossier for registration.
3	29/12/2022	MD/1293/01/2023	Immunohistochemistry Reagents (Brand: Dako Agilent)	119	DHS/RL/33/25SM/21, date: 14/10/2022	US $ 73,538.88	A & M Suhada Enterprises (Pvt) ltd	Agilent Technologies Singapore (International) Pte Ltd - Singapore	SPC Tender	Manufacturer is registered with NMRA. Submitted to WOR Committee held on 06/01/2023 and Decision was Pending Decision. Advised SPC to submit tender documents and details of evaluation.	Pending Decision. Advised SPC to submit tender documents & details of evaluation.
4	29/08/2022	MD/1057/09/2022	Immunohistochemistry Reagents	519	DHS/L/WW/81/014RS/22	US$ 16,555.40	A & M Suhada Enterprises (Pvt) ltd	Agilent Technologies Singapore - Singapore / Agilent Technologies Inc - US	SPC Order	Appeal. Manufacturer not registered under NMRA. Submitted to WOR Committee held on 06/01/2023 and Decision was Not recommended. Expedite the registration.	Recommended with condition. Subject to submission of the Dossier for registration. Advised SPC to submit SPC tender documents and TEC report.

25/03/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Approval
1	15/02/2023	MD/1418/02/2023	Listed Medical Items	As per the invoice	0020006875, date: 20/12/2022	GBP 40,130.98	Mines Advisory Group	SP Services (UK) Ltd - United Kingdom	Ongoing Operations in Nothern and Eastern Province of the country.(Donation by HQ in UK)		Recommended only for this consignment.
2	21/02/2023	MD/1431/02/2023	Pharmacy Refrigerator (Brand: Haier, Model: HYC-310)	2	HRP-005-Biomedica-2022, date: 2022/11/03	USD 1,320.00	Biomedica (Pvt) ltd	Haier Biomedical Co.ltd - China	For Office of the District Director of Health Services - Galle		Recommended only for this consignment.
3	28/02/2023	MD/1438/03/2023	1ml Syringe, 3ml Syringe, 10ml Syringe, 20ml Syringe and 60ml Syringe (Brand: Terumo)	As per the invoice	PFI-22/017, date: 08/02/2022	USD 3,387.60	Hemas Surgical & Diagnostics (Pvt) ltd	Terumo Corporation - Japan	Donation to Apeksha Hospital - Maharagama.		Recommended only for this consignment.
4	10/3/2023	MD/1444/03/2023	Real time Quantitative PCR (qPCR) based on Sso 7d fusion protein polymerase technology. (Brand: Sso Adv Universal Sybr SMX 1000.	2	EP/BRD/LSG/01/2023, date: 06/03/2023	USD 1,210.00	Emar Pharma (Pvt) ltd	Biorad Laboratories Inc - USA	For Department of Medical Microbiology & Immunology, Faculty of Medicine, University of Colombo. (Research Purpose)		Recommended only for this consignment.
5	10/3/2023	MD/1447/03/2023	Ultra Low Freezer (Brand: Haier , Model: DW-86L578ST)	1	HRP-001-BIOMEDICA-2023, date: 25/02/2023	USD 7,640.00	Biomedica (Pvt) ltd	Haier Biomedical Co.ltd - China	For University of Sabaragamuwa (Research Purpose)		Recommended only for this consignment.
6	10/3/2023	MD/1448/03/2023	Pacing Lead / Percutaneous Lead Introducer (Brand: Medtronic)	900	6211877133, date: 27/02/2023	USD 680,400.00	Medrac (Pvt) ltd	Medtronic - USA	For Health System Enhancement Project		Recommended only for this consignment. Advised to Expedite the registration.
7	10/3/2023	MD/1449/03/2023	Consumables for FRC Facility	125	FY23-SRI-0303002, date: 03/03/2023	USD 2,180.10	Emar Pharma (Pvt) ltd	Haemonetics Corporation - USA	For National Blood Transfusion Service		Recommended only for this consignment.
8	23/02/2023	MD/1432/02/2023	ACE-2 Fc Chimera, Human / SARS-COV-2 Spike Protein (Brand: Genscript)	1 x 3	U7887HE260001, date: 13/07/2022	USD $ 707.67	Biomedite (Pvt) ltd	Genscript Co.ltd - China	For Faculty of Medical Sciences, University of Sri Jayewardenepura (Research use only)		Recommended with condition. Subject to submission a valid letter of Ethical Review Committee. (Extension Letter)
9	3/3/2023	MD/1452/03/2023	Welch Allyn Blood Pressure Monitor - 767	As per the invoice	60384740, date: 01/11/2023	$11,114.00	A. Baur & Co. (pvt) ltd	Welch Allyn - Mexico	Donation (For Kaluthara District General Hospital) (By EN-Projects)		Recommended only for this consignment.
10	17/03/2023	MD/1462/03/2023	Administration Set of PD Solutions , PD Catheter Set	3200 Sets	UD/056 & 09/03/2023	& 70,400.00	MediGrow International SS (Pvt) Ltd	Manish MedicInnovation - India	For HSEP		Not recommended and advised to register the product.
11	16/03/2023	MD/1460/03/2023	Medical Devices/Equipments	As per the invoice	ZBS1-01/2023-DDP, ZBS1-02/2023-DDP, date: 17/02/2023	EUR 55,133.58 + EUR 2,800.00	Pfor. Inoka C.Perera, Department of Zoology and Environment Sciences, Faculty of Science, University of Colombo	Robert Koch Institute - Germany	For Research Purpose		Recommended with condition. Subject to submission a valid letter of Ethical Review Committee. (Extension Letter)
12	17/03/2023	MD/1463/03/2023	Phoenix M50 Instrument	1	203067271 Rev.01, date: 20/02/2023	USD 34,000.00	Medical Research Institute	BectonDickinson International - Belgium	Donation from WHO to MRI		Recommended only for this consignment.
13	17/03/2023	MD/1464/03/2023	Vertical Autoclave with Drying	2	203034820, date: 15/02/2023	USD 14,515.60	Medical Research Institute	Amex Export-Import GmbH - Austria	Donation from WHO to MRI		Recommended only for this consignment.
14	20/03/2023	MD/1467/03/2023	Hospital Beds and Mattresses	70 + 40	885, date: 18/03/2023	AU & 3900.00	Miistry of Health	Ceylon German Technical Training Institute Association - Australia	For Government of Sri Lanka		Recommended only for this consignment.
15	20/03/2023	MD/1468/03/2023	Used Wheel Chair	100	23-3-1, 01/03/2023	JPY 100,000.00	Sahana Sarana Social Welfare Foundation	Nihon Shakaifukushi Kohsaikai - Japan	Donation		Pending decision. Advised to submit a distribution List with accepting letters.
16	20/03/2023	MD/1465/03/2023	Troponin I Quantitative Test Device	100	E00023185, date: 13/03/2023	USD 13,000.00	A.R.S. Healthcare (Pvt) ltd	Quidel Cardiovascular Inc - USA	For Government Hospitals		Not recommended and advised to register the product.
17	20/03/2023	MD/1466/03/2023	Fully preloaded, hydrophobic & Monofocal Intra Ocular Lenses with Injector System	25000	DL/IOLs/25000/2023/02, date: 16/02/2023	EUR 2,000,000.00	Dimo (Pvt) ltd	Carl Zeiss Meditec AG - Germany			Not recommended. Expedite the registration.
18	22/03/2023	MD/1469/03/2023	ECG Machine	12	202451314, date: 06/02/2023	INR - 568,752.00	Ministry of Health	World Health Organization -India	Donation to government of Sri Lanka		Recommended only for this consignment.
19	22/03/2023	MD/1470/03/2023	HIV101 : HIV1/2 Stat Pak, 20 Test 60 Paks	60	IN366493, date: 10/02/2023	$1,584.00	Ministry of Health (National STD/AIDS Control Programme)	Chembio Diagnostics Systems Inc - United Status	Donation to STD/AIDS Control Programme		Recommended only for this consignment.
20	22/03/2023	MD/1471/03/2023	Syphilis, First Response Anti-TP Card, Kit of 25 Test	25	SCI/293/22-23, date: 24/02/2023	$10,937.50	Ministry of Health (National STD/AIDS Control Programme)	Premier Medical Corporation (Pvt) ltd - India	Donation to STD/AIDS Control Programme		Recommended only for this consignment.
21	22/03/2023	MD/1472/03/2023	Healthcare Products (Repellent, Deet 28% (Antibrum Forte), 150ml, spray btl, Repulsif Insecte, Deet 28%, (Antibrum Forte), 150ml, spray)	3	AEGVAM2300339, date: 17/03/2023	CHF 1,707.85	International Committee of the Red Cross	International Committee of the Red Cross - Geneva	For ICRC Staff Members		Recommended only for this consignment.
22	23/03/2023	MD/1473/03/2023	Recombinant Insulin Glargine 100U/ml, Insulin Delivery Device for Lilly 3ml insulin cartridges, Insulin Hhuman Regular 100u/ml	1724+1356+8970	80190979-Sri Lanka, date: 23/02/2023	USD $ 200.00	Sri Lanka College of Endocrinologists	Direct Relief - U.S.A	Donation to Sri Lanka College of Endocrinologists.		Recommended only for this consignment. Subject to submission of No Objection Letter from Local Agent.
23	24/03/2023	MD/1478/03/2023	Face Mask (tie-on type)	1,625,000 NOS	22-891, date: 20/03/2023	USD $ 49,020.11	Ministry of Health	Poornima Healthcare - India	Donation to government of Sri Lanka (From United Nations Office for Project Services - UNOPS)		Recommended only for this consignment.
24	27/12/2022	MD/1292/01/2023	Cysto-nephro Fiberscope (Brand: Olympus, Model: CYF-5A)	1	RSI-FY2023-189R, date: 19/12/2022	SGD 8,077.12	Technomedics International (Pvt) ltd	Olympus Medical Systems Corp - Japan	For Clear the Shipment	Appeal Submitted to WOR Committee held on 06/01/2023 and Decision was Not recommended. Expedite the registration.	Recommended only for this consignment.
25	30/01/2023	MD/1376/01/2023	Hoya Intraocular Lens - Fortable	1900	VSPI203790, date: 28/12/2022	USD 83925	Vision Solutions Lanka (Pvt) ltd	Hoya Medical Singapore Pte. Ltd - Singapore		Appeal Submitted to WOR Committee held on 11/02/2023 and Decision was Not recommended and advised to register the product.	Not recommended. Expedite the registration.

25/03/2023 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Approval
01	21/02/2023	MD/1430/02/2023	Electrode Jelly 260g Tube	210,000	LP/DHS/RL/141/187WAC/21, date: 02/01/2023	LKR 33,390,000.00	Emar Pharma (Pvt) ltd	Chhenna Corporation - India.	SPC Tender	Manufacturer registered with this local agent.	Recommended only for this consignment.
02	17/03/2023	MD/1461/03/2023	Micro Dissector (Cat no:DD312R) , (Model: Aesculap)	6	DHS/SUS/WW/122/183KM/22, date: 13/03/2023	EUR 540.36	B Braun Lanka (Pvt) Ltd	Aesculap AG - Germany	SPC Tender	Registered Manufacturer. Not registered sources for Micro - Dissector.	Recommended Only for this consignment.
03	14/03/2023	MD/1454/03/2023	C Reactive Protein Latex Agglutination 100 Tests/Kit	1000	DHS/ICL/X/RL/031/25SM/22, date: 28/10/2022	US$ 7,500.00	Elshaddai Enterprises (Pvt) ltd	Genuine Biosystem (Pvt) ltd - India	SPC ICL Tender		Refer to MDEC.
04	21/03/2023	MD/1474/03/2023	Pencil Point Spinal Needle, Extra long size 25G	3900	DHS/ICL/X/RSS/040/95NB/2022, date: 28/09/2022	USD $ 5,109.00	State Pharmaceuticals Corporation of Sri Lanka (Local Agent : Sheild Medical (Pvt) ltd)	M/s. Edges Medicare (Pvt) ltd - India	SPC ICL Tender		Refer to MDEC.
05	21/03/2023	MD/1475/03/2023	Spinal Needle / Angiographic Catheter	10110	DHS/ICL/X/RS/062/320DC/22, date: 06/10/2022	US $ 17,868.00	State Pharmaceuticals Corporation of Sri Lanka (Local Agent : Sheild Medical (Pvt) ltd)	M/s. Edges Medicare (Pvt) ltd - India	SPC ICL Tender		Refer to MDEC.
06	21/03/2023	MD/1476/03/2023	Dilatation Balloon Inflation Device	200	DHS/ICL/X/RS/063/316DC/22, date: 06/10/2022	$4,200.00	(Local Agent : Sheild Medical (Pvt) ltd (Local Agent : Sheild Medical (Pvt) ltd)	M/s. Edges Medicare (Pvt) ltd - India	SPC ICL Tender		Refer to MDEC.
07	21/03/2023	MD/1477/03/2023	Epidural Anaesthesia Sets	25,000	DHS/ICL/X/RS/061/420JT/22, date: 30/11/2022	$117,500.00	State Pharmaceuticals Corporation of Sri Lanka (Local Agent : Sheild Medical (Pvt) ltd)	M/s. Edges Medicare (Pvt) ltd - India	SPC ICL Tender		Refer to MDEC.

22/04/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
1	29/03/2023	MD/1479/04/2023	Micro Surgical Instruments	10 Nos x 7	EX-PI-22-0976, date: 17/02/2023	$1,220.00	Ministry of Health	"Nethsetha" Lions Vision for Sight Hospital Trust	Donation		Pending recommendation. Refer to get opinion from End-user.
2	09/03/2023	MD/1489/04/2023	Scalp Vein Set	8000	A02587, date: 15/02/2023	45,885.00	Ministry of Health	Chennai Surgicals - India	For Lions Club of Colombo Waters Meet (Donation)		Pending recommendation. Need clarification more data. 1. Requirement at MSD - with the distribution list. 2. Sample of Scalp Vein Set to be evaluated by the end-user.
3	03/04/2023	MD/1490/04/2023	iCare TA01i Tonometer set, TA01i, Standard B	30 Pcs	119723, date: 28/03/2023	EUR 60,389.00	Ministry of Health	Icare Finland Oy - Vantaa	From Sight for All - Australia, humanitarian aid to Government of Sri Lanka. (Donation)		Recommended only for this consignment.
4	03/04/2023	MD/1491/04/2023	SUrgical Suture Materials (SeamCryl USP, SeamPDS USP, SeamLene USP)	195 + 195 + 195	PI-EXP-2223-27, date: 28/03/2023	USD 5,063.00	Ministry of Health	Surgical Sutures (Pvt) ltd - Bangalore	Donation		Recommended only for this consignment.
5	03/04/2023	MD/1492/04/2023	ICU Hospital Beds / Wheel Chairs / Walkers / Commod Chairs / Crutches / Hospital Medical Trolly	20 + 100 + 50 + 30 + 300 + 50	01042023, date: 01/04/2023	$1,200.00	Ministry of Health	Mahakaruna Buddhist Society - Singapore	Donation		Recommended only for this consignment.
6	04/04/2023	MD/1493/04/2023	Medical Devices/Equipments	As per the invoice	MS/CDS, date: 14/03/2023	INR 1,333,241.00	Ministry of Health	World Health Organization - India	Donation		Recommended only for this consignment.
7	06/04/2023	MD/1494/04/2023	Medical Devices/Equipments	3	PE5588, date: 04/04/2023	USD 31,026.00	Ministry of Health	Peak International Trade (Tianjin) Co.ltd - China	Donation. (From United Nations Children's Fund)		Recommended only for this consignment.
8	10/04/2023	MD/1495/04/2023	Medical Devices/Equipments	As per the invoice	6205, date: 13/11/2022	As per the invoice	Ministry of Health	Ashiqe Medicals - India	Donation (From Auslmat)		Recommended only for this consignment.
9	17/04/2023	MD/1496/04/2023	Blood Glucose Test Strips	500,000 Pcs	2023-24/0064, date: 05/04/2023	$60,000.00	Ministry of Health	International Scientific Instrument Co. - New Delhi	Donation (from United Nations Office for Project Services)		Pending Recommendation. Need to confirm the compatibility with existing Glucometers in Sri Lanka.
10	17/04/2023	MD/1500/04/2023	Face Mask (tie - on type)	1,625,000	22-920, date: 28/03/2023	$49,020.11	Ministry of Health	Poornima Health Care - India	Donation (From UNOPS)		Recommended only for this consignment.
11	06/04/2023	MD/1501/04/2023	Model Premium RX 580 - Complete Medical Oxygen Generating Plant with Standard Accessories	As per the invoice	2110166, date: 29/09/2022	EUR 321,303.00	Ministry of Health	Novair S.A.S - France	Donation (From United Nations Children's Fund)		Recommended only for this consignment.
12	22/03/2023	MD/1480/04/2023	Liquid Nitrogen tank (35L & 30L)	2	CO2604851, date: 27/02/2023	USD 1,157.14	Medical Research Institute	Fleischhacker LLp - Singapore	Donation from WHO		Recommended only for this consignment.
13	22/03/2023	MD/1481/04/2023	Crystal Violet 100g (01), Choroform Letter (02)	3	2205028594, date: 06/07/2022	EUR 91.00	Medical Research Institute	VWR International GmbH - Austria	Donation from WHO		Recommended only for this consignment.
14	22/03/2023	MD/1482/04/2023	Heat Indicator tape (21), Micro test tube (02), FTA classic card pack (124), Polyester Sealing Film (05)	As per the invoice	258278, date: 27/01/2023	USD 20,860.40	Medical Research Institute	Jalan Teknokrat 6 - Malaysia	Donation from WHO		Recommended only for this consignment.
15	22/03/2023	MD/1483/04/2023	Bench Top Centrifuge with Rotor	1	DPE/22-23/7434 Temp, date: 21/02/2023	USD 2,648.00	Medical Research Institute	Deepak Care Limited - New Delhi	Donation from WHO		Recommended only for this consignment.
16	03/04/2023	MD/1498/04/2023	Sterilizer - Sterilizer System and Spare Parts, Standard Accessories (Getinge HS 66 Hospital Steilizer) (Brand: Geting, Model: HS Series)	As per the invoice	8085413307, date: 17.03.2023	USD 8,529.69	Mediquipment Limited	Getinge AB - Sweden	For Biomedical Engineering Unit - Matara	Existing Registration. (Ref: DVR-11509). Expired on 2019.	Recommended only for this consignment.
17	27/03/2023	MD/1488/04/2023	Medical Compression Stockings Anti - Embolism Stockings	As per the invoice	20230124.01, date: 06/02/2023	Eur 23,542.90	CIC Holdings PLC	Varimed Medikal San - Turkiye		Manufacturer not registered with NMRA.	Not recommended and advised to register the product.
18	30/03/2023	MD/1485/04/2023	Soft Roll / 100% Wrinkled Cotton Crape Bandage	Soft Roll (4000Pcs + 2000Pcs) , 100% Coton Cepe Bandage (4800Pcs + 2400Pcs + 3200Pcs)	SU20230324, date: 24/03/2023	US $ 5,467.84	Medica Pharmaceuticals (Pvt) Ltd	Yangzhou Super Union Import & Export Co.ltd - China	For Sri Lanka Army Medical Corporation	Manufacturer is registered under NMRA with "Canoe Medicare (Pvt) ltd - Sri Lanka" for Surgical Face Masks. (Ref: number - D/2888)	Not recommended and advised to register the product.
19	14/03/2023	MD/1453/03/2023	Life Signals Multiparameter Remote Monitoring System and Spare Parts Accessories (Brand:Biosensor , Model LX 1550)	50	01032023/HEMAS, date: 01/03/2023	$500.00	Hemas Surgical & Diagnostics ( Pvt) ltd	Life Signals Inc - USA	For Testing and Examination Purposes.	Manufacturer is not registered under NMRA.	Pending Recommendation. Submit a detail report of the study with the approved proposal, Ethic Committee Approvals, Letter from the study center, Details of the investigators etc.
20	20/04/2023	MD/1504/04/2023	Laboratory Supplies (VTM)	1	034/2023, PO: MS/WHE, date: 19/04/2023	USD 30.00	Ministry of Health	World Health Organization - India	Donation		Recommended if it for Viral Transport Medium. If not the above, need additional information. Please confirm the name of the device.
21	19/04/2023	MD/1505/04/2023	Module, Glucometer, 300 test with Lancets	2000	203122051, date: 18/04/2023	USD 98,420.00	Ministry of Health	World Health Organization - Malaysia	Donation		Recommended only for this consignment.
22	20/04/2023	MD/1506/04/2023	LCD Oxygen Monitor	40	23/00666, date: 07/03/2023	USD 28,783.90	Ministry of Health	Amex Export-Import GmbH - Austria	Donation		Pending Recommendation. Advised to submit the recommendation from the end-user with the details of the product.
23	21/04/2023	MD/1507/04/2023	Wheel Chairs / Clutches	25 + 3	N/A	N/A	Ceylon Foiage (Pvt) ltd	Takotomi Foundation - Japan	For Boad of Investment of Sri Lanka and Divisional Hospital - Boralanda		Recommended only for this consignment.
24	21/04/2023	MD/1511/04/2023	Biological Safety Cabinet, Liquid Nitrogen Tank	8	HRP-002-BIOMEDICA-2023, date: 20/03/2023	USD 7,010	Biomedica (Pvt) ltd	Haier Biomedical Co.ltd - China	For New Maternity Hospital - Galle		Recommended only for this consignment.
25	21/04/2023	MD/1512/04/2023	Spectra Optia Exchange Set, EA / Spectra Optia IDL Set	6 + 4	950089652, date: 15/03/2023	7,800.00	Hemas Surgicals & Diagnostics (Pvt) ltd	Terumo BCT Asia Pte. ltd - Singapore	For National Blood Transfusion Service		Recommended only for this consignment. (Registered product. Site change process in progress.)
26	21/04/2023	MD/1513/04/2023	UN3373, Biological Substance, Category B Materials.	01 Parcel	AWB - 1541838255, date: 10/03/2023	-	Medical Research Insitute	Chulalongkorn University - Thailand.	Donation		Recommended only for this consignment.
27	21/04/2023	MD/1514/04/2023	Phosphate Saline / Dimethyl Sulfoxide	250 + 03	23/00835, date: 20/032023	USD 2688.40	Medical Research Insitute	Amex Export-Import GmbH - Austria	Donation		Recommended only for this consignment.
28	16/03/2023	MD/1460/03/2023	Medical Devices/Equipments	As per the invoice	ZBS1-01/2023-DDP, ZBS1-02/2023-DDP, date: 17/02/2023	EUR 55,133.58 + EUR 2,800.00	Pfor. Inoka C.Perera, Department of Zoology and Environment Sciences, Faculty of Science, University of Colombo	Robert Koch Institute - Germany	For Research Purpose	Submitted to WOR Committee held on 25/02/2023 and Decision was Recommended with condition. Subject to submission a valid letter of Ethical Review Committee. (Extension Letter). An extension has been applied for but the MRI Ethics Committee has not yet met and has been informed that there are technical issues in convening it. WOR is requested on the condition of granting the extension.	Recommended with condition. Subject to submission of Official letter confirming current situation given in the email. (Can be issued. There is an official letter confirming current situation given in the email.)

22/04/2023 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Recommendation
1	30/03/2023	MD/1484/04/2023	Cilia Forceps (Duckworth & Kent)	50 Nos	DHS/RS/RQ/181/21, date:25/03/2023	LKR 4,875,000.00	Mervynsons (Pvt) ltd	Dockworth & Kent Ltd - UK	SPC Tender	Dossier Submitted for product registration - Not evaluated. (D/4032) Manufacturer is registered under NMRA with Hemas Pharmaceuticals for different product.	Recommended only for his consignment.
2	3/4/2023	MD/1502/04/2023	Anticoagulant Solution 500ml	3000	LP/DHS/SUS/WW/1/07NB/2023, date: 07/03/2023	LKR 195,000,000.00	Emar Pharma (Pvt) ltd	Haemonetics SA - Switzerland	SPC Tender	Haemonetics S.A - Switzerlandis available as a legal manufacturer for different products registered with Emar Pharma. (Ref: D/488, D/489)	Recommended only for this consignment.

30/05/2023
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks WOR Committee Recommendation
01	19/05/2023	MD/1554/05/2023	Medical Devices/Equipments	As per the invoice	Equip-Charity-16, date: 06/04/2023	E 4,770.00	Meththa Foundation	Meththa Foundation - UK	For Meththa Foundation	Recommended only for this consignment. Advised to submit the distribution list.
02	12/05/2023	MD/1550/05/2023	Long Bulb Celcius Clinical Thermometer	120	57738, date: 02/03/2022		Hunter & Company PLC	G H Zeal Ltd - UK	For	Not recommended and advised to register the product.
03	25/04/2023	MD/1517/05/2023	Spare Parts for Hematology Analyzer (Brand: Nihon Kohden Japan)	As per the invoice	10038850, date: 18/04/2023 (PO:5500015089)	USD 30,066.28	Hemas Surgicals & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Sri Lanka Air Force Headquarters	Recommended only for this consignment.
04	12/05/2023	MD/1548/05/2023	Spare Parts for EEG and ECG Machine (Brand: Nihon Kohden)	As per the invoice	10038946, date: 20/04/2023	USD 23,473.44	Hemas Surgicals & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Several government Hospital in Sri Lanka. (District General Hospital-Matara, teaching Hospital - Batticaloa, Teaching Hospital - Anuradhapura, Teaching Hospital - Kurunegala)	Recommended only for this consignment.
05	12/05/2023	MD/1549/05/2023	Controls, Calibrators and Reagents for Hemotology Analyzer	As per the invoice	10038132, date: 24/03/2023 , MYU-76-2023, date: 07/04/2023	USD 26,867.00 + USD 775.00	Hemas Surgicals & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Sri Lanka Air Force and Department of Health Service-North Western Province	Recommended only for this consignment.
06	25/04/2023	MD/1519/05/2023	BIT CD EMRLD 22 LYSE (Brand: Abbott)	15	ADD/PF/A632/2023/PAK/GMBH, date: 29/03/2023	US $ 1260.00	Hemas Surgicals & Diagnostics (Pvt) ltd	Abbott Laboratories - USA	For Asiri Hospital Holdings PLC - Anuradhapura	Not recommended. Expedite the registration.
07	08/05/2023	MD/1538/05/2023	Blood Plasma Freezer	2	178/00, date: 27/02/2023	8,980.00	Premium International (Pvt) ltd	KW Apparecchi Scientifici S.R.L - Italy	For Karapitiya Maternity Hospital	Recommended only for this consignment.
08	08/05/2023	MD/1531/05/2023	Blood Bag Refrigerator	2	178/00, date: 27/02/2023	6,100.00	Premium International (Pvt) ltd	KW Apparecchi Scientifici S.R.L - Italy	For Karapitiya Maternity Hospital	Recommended only for this consignment. Advised to apply for registration.
09	08/05/2023	MD/1532/05/2023	Vertical Autoclave	1	XHC230302002, date: 17/03/2023	USD 1,275.00	Premium International (Pvt) ltd	Shinva Medical Instrument CO.ltd - China	For Karapitiya Maternity Hospital	Not recommended and advised to register the product.
10	08/05/2023	MD/1533/05/2023	Endoscope Washer-disinfector	1	XHC230220003, date: 17/03/2023	USD 13,358.00	Premium International (Pvt) ltd	Shinva Medical Instrument CO.ltd - China	For Karapitiya Maternity Hospital	Not recommended and advised to register the product.
11	08/05/2023	MD/1535/05/2023	Centrifuges and Accessories	As per the invoice	HI-TE-030-1, date: 27/04/2023, HI-TE-030-2, date: 27/04/2023	EUR 41,280.00 + EUR 25,220.00	Premium International (Pvt) ltd	Hetich Asia Pacific Pte Ltd - Singapore	For Karapitiya Maternity Hospital	Not recommended and advised to register the product.
12	23/05/2023	MD/1565/05/2023	Upright Laboratory Freezer (KW Apparecchi Scientifici - KBPF 600PP PL ADV)	1	178/00, date: 27/02/2023	4,750.00	Premium International (Pvt) ltd	KW Apparecchi Scientifici S.r.L. - Italy	For Karapitiya Maternity Hospital	Recommended only for this consignment. Advised to apply for registration.
13	23/05/2023	MD/1566/05/2023	Upright Refrigerator (KW Apparecchi Scientifici - KBPR 600V NG, KBPR 400V NG)	15 + 8	178/00, 27/02/2023	21,750.00 + 10,800.00	Premium International (Pvt) ltd	KW Apparecchi Scientifici S.r.L. - Italy	For Karapitiya Maternity Hospital	Recommended only for this consignment. Advised to apply for registration.
14	23/05/2023	MD/1567/05/2023	HLA Transplant Reagents and Consumables	As per the invoice	P1014000163, date: 18/05/2023	As per the invoice	Premium International (Pvt) ltd	Immucor GTI Diagnostics Inc - USA	For National Blood Transfusion Services	Not recommended. Expedite the registration. (Already two registered sources available and sample license already issued.)
15	25/05/2023	MD/1569/05/2023	Tissue Embedding System	2	230500034, date: 19/05/2023	As per the invoice	Premium International (Pvt) ltd	Sakura Finetek Japan Co.ltd - Tokyo	For Department of Health Services - Sabaragamuwa Province.	Not recommended. Expedite the registration. (Sample license already issued.)
16	08/05/2023	MD/1536/05/2023	Sterilizer System and Spare Parts, Standard Accessories (Getinge Syeam Sterilizer)	4	8085412348, date: 14/09/2023	USD 541.36	Mediquipment Limited	Getinge Sterilization AB - Sweden	For Wathupitiwala Base Hospital and General Sir John Kotelawala Defence University Hospital	Recommended only for this consignment.
17	08/05/2023	MD/1537/05/2023	Sterilizer System and Spare Parts, Standard Accessories (Getinge Syeam Sterilizer)	As per the invoice	8085413437, date: 10/04/2023 and 8085413426, date: 06/04/2023	USD 892.28 + USD 13795.94	Mediquipment Limited	Getinge Sterilization AB - Sweden	For Wathupitiwala Base Hospital and Kalmunai Base Hospital	Recommended only for this consignment.
18	12/05/2023	MD/1543/05/2023	Lab Consumables	As per the invoice	2000926395, date: 25/04/2023	USD 1646.24	A. Baur & Co. (Pvt) ltd	Becton Dickinsons Co.- USA	For Department of Clinical Medicine, Faculty of Medicine, University of Colombo	Recommended only for this consignment.
19	23/05/2023	MD/1560/05/2023	Wallace Catheters & Oocyte Recovery Set	420	OIPL/23-24/PI/AB/001, date: 27/04/2023	$29,652.00	A. Baur & Co. (Pvt) ltd	Cooper Surgical Inc - USA	For Several Private Hospitals in Sri Lanka	Not recommended and advised to register the product. (Manufacture registered with another local agent.)
20	12/05/2023	MD/1551/05/2023	Micromanipulation Ppettes (Vitrolife) (ICSI Pippetes, Holding Pipettes)	44 + 55	454492, date: 2023/05/09	EUR 7640.00	A. Baur & Co. (Pvt) ltd	Vitrolife Inc - USA	For Several Private Hospitals in Sri Lanka	Not recommended. Expedite the registration.
21	23/05/2023	MD/1562/05/2023	Elisa Test Kits	4	899069, date: 12/05/2023	$2,075.00	Emar Pharma (Pvt) ltd	My BioSource Inc - USA	For Ministry of Higher Education Technology and Innovation	Recommended only for this consignment.
22	25/05/2023	MD/1571/05/2023	FLAER (Alexa 488 Proaerolysin Variant)	4	1074122, date: 18/05/2023	USD 1,170.00	Emar Pharma (Pvt) ltd	Cedarlane Corporation - Canada	For Medical Research Institute	Recommended only for this consignment.
23	14/03/2023	MD/1453/03/2023	Life Signals Multiparameter Remote Monitoring System and Spare Parts Accessories (Brand:Biosensor , Model LX 1550)	50	01032023/HEMAS, date: 01/03/2023	$500.00	Hemas Surgical & Diagnostics (Pvt) ltd	Life Signals Inc - USA	For Testing and Examination Purposes.	Submitted to WOR Committee held on 22/04/2023 and Decision was Pending Recommendation. Submit a detail report of the study with the approved proposal, Ethic Committee Approvals, Letter from the study center, Details of the investigators etc.	Pending decision. Instructed to submit reports for product with prior WOR approval.
24	12/05/2023	MD/1544/05/2023	Administration Set for Peritoneal Dialysis Solution with two lead / Peritoneal dialysis catheter set for Peritoneal dialysis and Peritoneal lavage	1600 + 1600	UD/056, date: 09/03/2023	USD 70,400.00	Medigrow International SS (Pvt) ltd	Manish Medi Innovation - India	For Health System Enhancement Project	Appeal Submitted to WOR Committee held on 25/03/2023 and Decision was Not recommended and advised to register the product.	Not recommended and advised to register the product.
25	10/05/2023	MD/1568/05/2023	H2 O2 Hydra Facial Machine (Home Skin Care)	1	XMBR78096663, date: 21/04/2023	USD 284.13	Dr. D.G.I.N. Wijerathne	SZ XH Import & Export Co. Ltd - China	For Anesthetic Medical Praing Programme for doctors.	Not recommended and advised to register the product.
26	20/04/2023	MD/1506/04/2023	LCD Oxygen Monitor	40	23/00666, date: 07/03/2023	USD 28,783.90	Ministry of Health	Amex Export-Import GmbH - Austria	Donation	Submitted to WOR Committee held on 22/04/2023 and Decision was Pending Recommendation. Advised to submit the recommendation from the end-user with the details of the product.	Pending decision. NMRA was instructed to evaluate the sample with Ceylon Oxygen (Pvt) Ltd.

30/05/2023 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	WOR Committee Recommendation
1	21/04/2023	MD/1510/04/2023	Oxygen Masks / Hudson Mask with tubing for adult	150,000 NOS	LP/DHS/RS/EP/61/486AK/22, date: 06/04/2023	LKR 41,250,000.00	Sethmedi International (Pvt) ltd	Guangdong Ecan Medical Co.ltd - China	SPC Tender	Not recommended and advised to register the product. Advised to submit the samples for end-user evaluation. (College of Anesthesiologists)
2	10/04/2023	MD/1499/04/2023	Activated partial thromboplastin time reagent (lupas sensitive) with calcium	260+65	LP/DHS/RL/EP/25/83SR/22, date: 01/02/2023	LKR 1,770,678.00	Biomedite (Pvt) ltd	Technoclone Herstellung Von Diagnostika und Arzneimtteln GmbH - Austria	SPC Tender	Not recommended. Advised to purchase from registered source. (Registered source available.)
3	12/05/2023	MD/1552/05/2023	Trabecular Metal Implants for Revision Hip Surgery (Zimmer)	100	DHS/RSS/RQ/191/611BS/21, date: 04/10/2022	US $ 578,400.00	Zodiac Medicals (Pvt) ltd	Zimmer (Pte) ltd	SPC Tender	Recommended only for this consignment.
4	13/02/203	MD/1421/02/2023	"8" Instrument Set for figure eight bone plates in sterilizing tray with 100 implants	18 NOS	LP/DHS/SUS/WW/206/583KM/21, date: 29/08/2022	LKR 49,788,000.00	Medisurge International	Sigma Surgical (Pvt) ltd - India	SPC Tender	Recommended only for this consignment. Subject to submission of the renewal.

Waiver of Registration Committee - Device (July 2022 to December 2022)

Waiver of Registration Committee - Medical Device (July 2022 to December 2022)
13/07/2022
	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Approval
1	15/06/2022	MD/831/06/2022	Main Stretcher , Foldaway Stretcher(for ford ambulances),		N/A	Future Automobiles (Pvt) ltd	Jiangsu Rixin Medical Equipment co.ltd - China	For Ministry of Health (Not a DonatHeion)	Manufacturer is registered under NMRA with Local Agent "Access international". (No current valid registrations for the product.) ISO, EC certificates and registration document of US FDA are submitted	Not recommended. Need a recommendation from college of anesthesiology. Advised to arrange an inspection with college members of anesthesiology.
	Same as above	Same as above	Portable Oxygen Therapy Kit,		N/A	Same as above	Medbirlesim - Turkey	For Ministry of Health (Not a Donation)	Manufacturer not registered ISO, EC certificates are submitted.
	Same as above	Same as above	First Aid Bag (for ford ambulances),		N/A	Same as above	Medbirlesim - Turkey	For Ministry of Health (Not a Donation)	Manufacturer not registered ISO, EC certificates are submitted.
2	24/06/2022	MD/837/06/2022	Motivation Multisport Wheelchair (Brand : Merits, Model : WM4SP-02))	20	SI002783, date: 13/06/2022	Sri Lanka Tennis Association	Merits (China) under license from Motivation (UK)	Donation From ITF to the SLTA with the aim of further developing Wheelchair Tennis in Sri Lanka.	Manufacturer not registered under NMRA.	Recommended only for this consignment.
3	22/06/2022	MD/838/06/2022	Cervial Collars, Rigid Splint Cervical Collors and Collar with Trache Opening (Brand: OPPO)	2775	OP01-202204011, date: 29/04/2022	Hemas Surgical & Diagnostics (Pvt) ltd	OPPO Medical Corporation - Taiwan		Already registered product. (File: D/147/RR) Manufacturing site changed and new site is registered with NMRA very reason. (File: T/174)	Not recommended and advised to register the product.
4	23/06/2022	MD/842/06/2022	Phacoemulsification Stem with accessories & Spare Parts (Brand : White star Signature PRO) / Life Signals multipara meter remote monitoring system and spare parts Accessories	1 + 14	199055, date : 2/11/2021, 24032022/HEMAS, date: 24/03/2022	Hemas Pharmaceuticals (Pvt) ltd	Johnson & Johnson Surgical Vision Inc - USA / Life Signals Inc - USA	For Whitestar Signature PRO System / For Testing and Examination Purpose.	· Accessories for already registered Item. (File D/1905) · These are supplied on free of charge basis for the purpose of variant replacement.	Recommended only for this consignment.
5	22/06/2022	MD/844/06/2022	Air Mettress (Brand: Fitconn, Model: FU-AM001)	2700	P22309JN151, date: 09/03/2022	Medica Pharmaceuticals (Pvt) ltd	Shenzhen Fitvonn Technology Co.ltd - China	to cover the shortage in Sri Lanka Market	Manufacture is not registered with NMRA. Registered sources available.	Not recommended and advised to register the product.
6	22/06/2022	MD/845/06/2022	Wheelchairs	328	HBDS2204297152, date: 2022/04/29	Medica Pharmaceuticals (Pvt) ltd	Hebei Dansong Medical Equipment Co.ltd - China	to cover the shortage in Sri Lanka Market	Manufacture is not registered with NMRA. Registered sources available.	Not recommended and advised to register the product.
7	22/06/2022	MD/846/06/2022	Portable Otoacoustic Test Device(OtoRead)	N/A	N/A	J.M. Wickramarachchi & Company (Pvt) ltd	Interacoustics A/S - Denmark	For Biomedical Engineering Services	Manufacturer registered with NMRA.	Recommended with condition. Subject to submission of dossier for registration.
8	15/06/2022	MD/847/06/2022	Premium Plus CEEA, GIA, Endo GIA, VOLC180, Protack, TA	As per the invoice	6202313769, date: 27/05/2022	A. Baur & Co. (Pvt) ltd	Covidien LLC - USA	For Government and Private Hospitals	Agency Transfer from Ceyoka to A Buars. Copy of registration certificate issued to previous local agent not submitted.	Recommended with condition. Subject to NOL from Ceyoka (Pvt) ltd.
9	05/07/2022	MD/859/07/2022	Laboratory reagents and supplies	As per the invoice	date: 27/06/2022	Dr. Lakkumar Fernando	Johns Hopkins Bloomberg School of Public Health - USA	For Research Purpose	Donation	Recommended only for this consignment.
10	05/07/2022	MD/860/07/2022	Reagents for Hematology Analyzer	750	5500014368, date: 21/06/2022	Hemas Surgical & Diagnostics (Pvt) ltd	Nihon Kohden Japan	For Sri Lanka Air Force Headquarters	-	Recommended only for this consignment.
11	30/06/2022	MD/862/07/2022	Urine Reagent Strips (10 parameter) test kits	200	47709, date: 28/04/2022	DN Medical Corporation (Pvt) ltd	Cortez Diagnostics Inc - USA	For Government Institution and Pricat Sector (Diabetes Association of Sri Lanka, General Sir John Kotelawala Defence University, Gall Co-op Hospital ltd, Ohlums Clinic & Laboratories (Pvt) ltd, Medna Healthcare, Dhanvantharii Hospital - Trincomalee, Wayamba Medical Center, C-Care Pharmacentical - Kandy, Medi-Care - rathnapura.)	Already registered item and site changed. (DVR 360 RR) Valid till Dec.2022. SIL applied for new product.	Not recommended. Expedite the registration.
12	30/06/2022	MD/863/07/2022	Urine HCG Pregnancy Rapid Test Kits (Brand : Insta Test)	30000	47709, date: 28/04/2022	DN Medical Corporation (Pvt) ltd	Cortez Diagnostics Inc - USA	For Government Institution and Pricat Sector (Lanka Hospital - Colombo 5, Galle Co-Op Hospital ltd, Cargills Foods Company (Pvt) ltd, Sri Jayawardenepra General Hospital, Ohlums Clinic & Laboratories (Pvt) ltd, HEMAS - wattala, Healthguard Pharmacy Ltd - Kelaniya, Richard Pieris Distributors Ltd, C-Care Pharmacentical - Kandy, Medna Health Care - Puwakpitiya, Wayamba Medical Center, Dhanavantharii Hospital - Trincomalee, Medi Care - Rathnapura)	Already registered product. (DVR 157 RR) and expedited may 2022. Manufacturer site changed and SIL applied to submit fresh file.	Not recommended. Expedite the registration.
13	01/07/2022	MD/864/07/2022	Video Colonoscopy (Brand:Olympus, Model:CF-Q150L)	1	RPI-FY2023-008, date: 21/06/2022	Mediquipment Limited	Olympus Medical Systems Cooperation - Japan	Repaired Item (For Ruhunu Hospital (Pvt) ltd)	Repaired Items.	Recommended only for this consignment.
14	05/07/2022	MD/867/07/2022	Platelet Aggregometer with standard accessories (Brand: Helena)	As per the invoice	318657, date: 17/05/2022	Analytical Instruments	Helena Bioscience Europe - United Kingdom	For Medical Research Institute and Teaching Hospital - Peradeniya.	Renewal is under processing. (D/1136RR) Expired June 2022.	Recommended only for this consignment.
15	05/07/2022		Medical Devices/Equipments	As per the invoice	3977184, date: 03/06/2022	Prof. Prasanna Galhena, Director, Institue of Biochemistry, Molecular Biology and Biotechnology, University of Colombo	Agilent Technologies - Singapore	For Research and Development Purpose and not for human diagnostic or therapeutic use.	Donation	Recommended with condition. Subject to submission of Ethic Committee Clearance Letter.
16	01/07/2022	MD/854/07/2022	Hospital Beds	As per the invoice	22HC132A, date: 6/6/2022	AP Lanka (Pvt) ltd	Ningbo Hecai Medical Equipment Co.ltd - China	For Sri Jayewardenepura General Hospital and Postgraduate Medical Training Center	Donation	Recommended only for this consignment.
17	08/07/2022	MD/869/07/2022	QFT-Plus 2 Plate Kit ELISA, QFT- Plus tubes.	20	93394498, date:22/06/2022	Microtech Biological (Pvt) ltd	QIAGEN GmbH - Germany	For several Private Hospitals.	As per the data base registration (D/1248) still not recommended by the panel. Need to check the file. The local agent submitted additional data.	Not recommended. Expedite the registration.
18	08/07/2022	MD/870/07/2022	Sterilizer System and Standard Accessories, Spare Parts.	03	8085411955, date: 28/06/2022	Mediquipment Limited	Getinge Sterilization AB - Sweden.	Repaired Item. For Regional Director of Health Services - Gampaha and Asiri Hospital - Kandy.	Registered product and expired. Also product discussed by the manufacture. (DVR 11509) Regulating to import spare parts to repair already supplied machines at RDHS-Gampaha and Asiri Hospital.	Recommended only for this consignment.
19	08/07/2022	MD/871/07/2022	GeneXpert MTB/RIF Kit and MTB/RIF Ultra Kit	As per the invoice	9001103080, date: 24/05/2022	National Programme for Tuberculosis Control & Chest Diseases	UNOPS	Donation to TB	Donation	Recommended only for this consignment.
20	08/07/2022	MD/872/07/2022	Detection Kits for real time PCR	13	0000702270, date: 21/06/2022	Emar Pharma (Pvt) ltd	Primer Design Ltd - UK	For Asiri Surgical Hospital - Colombo 05	New manufacturer not registered under NMRA.	Not recommended and advised to register the product.
21	08/07/2022	MD/873/07/2022	Viral Medium Transport Kits	1000	7121300634, date: 05/03/2022	Siba Holdings (pvt) ltd	Meril Diagnostics (Pvt) ltd - India		D/3986 is pending for panel evaluation.	Not recommended. Expedite the registration.
22	08/07/2022	MD/874/07/2022	Solas Liferaft/Lifeboat First Aid Kit	60		C.G.V. Antony & Sons (Pte) Ltd	BCB International Ltd - UK	Imported to export ships use.		Recommended only for this consignment.
23	09/05/2022	MD/784/05/2022	Hyperbaric Oxygen Therapy	1	RE2022-026P, date: 27/04/2022	Analytical Instruments	Haux-Life-Support GmbH - Germany	For Ministry of Defence	Manufacturer is not registered. WOR Committee held on 11/06/2022 and committee decision was Not recommended and advised to register the product. Apply for registration to expedite.	Pending Decision. Get an opinion from College of Physicians.
24	9/9/2021	MD/07/09/2021	Oxygen Production Plant, Generator (Oxymat - Slovakia)	1	Tender Number:UNOPS-22900-EPP-030R, date:02/09/2021	Delmege Forsyth & Co.ltd	Process Engineering S.r.l - Milano	UNOPS Tender.	WOR Committee held on 11/12/2021 and committee decision was Pending Decision. Committee advised to send a letter Director DGHS, Director - BMES and Director - Logistics. Biomedical Engineering Services sent a reply to this.	Pending Decision. Advised to send a letter Director (Building), Ministry of Health for evaluate the product.

13/07/2022 - S.P.C
	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Approval
1	22/06/2022	MD/839/06/2022	Urinary Catheter / Clean Intermittent Catheterization Catheter (CIC Catheter) (Brand: Devon CIC)	5970	DHS/ICL/X/RSS/001/39NB/2022, date: 07/06/2022	R & D Intertrades (Pvt) ltd	Devon Innovations (Pvt) ltd - India	SPC Tender (Under Indian Credit line)	· For SPC Supply. · Registration expired in 2017 and not apply for renewal. (File DVR-417-RR) · Sample import license issued recently to submit new file, but file still not submitted. · SPC not submitted TEC Document.	Recommended with condition. Expedite the registration or Subject to submission of SPC TEC Document.
2	22/06/2022	MD/840/06/2022	Bladder Drainage (Urethral) Catheter	2000	DHS/ICL/X/RSS/001/33NB/22, date: 06/06/2022	Medica Pharmaceuticals (Pvt) ltd	Leelavathy Medical Devices Company - India	SPC Tender (Under Indian Credit line)	· For SPC. · New manufacturer not registered with NMRA. · SPC not submitted TEC Document. · Registered sources available.	Recommended with Condition. Subject to submission of TEC Documents.
3	23/06/2022	MD/841/06/2022	Dental Instruments (Dental Probs, Dental Hand Scaler, Gum Scissors, Excavator, Osteo-Mitchell Carver) (Brand: Snaa)	As per the invoice	DHS/S/WW/208/21, date: 29/09/2020	Rivomed Holdings (Pvt) ltd	Snaa Industries - Pakistan	SPC Tender	· Manufacturer registered with another local agent Indro (Pvt) ltd As per NMRA database. · SPC submitted TEC Document.	Not recommended and advised to register the product.
4	23/06/2022	MD/843/06/2022	Un cuffed/ cuffed Endotracheal Tubes Nylon/Steel Reinforced	As per the invoice	DHS/ICL.X/RS/038/2022, date: 31/03/2022	Nextgen Healthcare	La-Med Healthcare Pvt ltd - India	SPC Tender (Under Indian Credit line)	· For SPC. · Manufacturer already registered with this local agent. · SPC submitted TEC Document.	Recommended with condition. Subject to submission of Letter of award.
5	05/07/2022	MD/861/07/2022	Fully Automated Biopsy Gun	As per the indent	DHS/ICL/X/RS/036/2022, date: 31/03/2022	Kish International (Pvt) ltd	St. Stone Medical Devices (Pvt) ltd	SPC Tender (Under Indian Credit line)	· SPC not submitted TEC Document. · Manufacturer registered with NMRA.	Recommended with condition. Subject to submission of TEC documents and SPC Letter of award.
6	08/07/2022	MD/875/07/2022	Peritoneal Dialysis Catheter/ Peritoneal Dialysis Catheter Sets	As per the indent	DHS.ICL/X/RSS/016/43PL/22, date: 16/06/2022	MediGrow International SS (Pvt) ltd	Manish Medi Innovation - India	SPC Tender (Under Indian Credit line)	· SPC not submitted TEC Document. · Manufacturer not registered with NMRA. · Three registered sources available.	Recommended with condition. Subject to submission of TEC documents and letter of award.
7	27/05/2022	MD/802/06/2022	Riboflavin Solution for Control Cross-Linking (CXL)	400	DHS/P/WW/324/22, date: 09/11/2021	Lenstech Innovations (Pvt) ltd	Ophthalmica (Pty) Ltd - South Korea	SPC Tender	Manufacturer not registered with NMRA. WOR Committee held on 11/06/2022 and committee decision was Not coming Under NMRA. Issue Product Categorization.	Not recommended and advised to register the product.
8	06/06/2022	MD/815/06/2022	Dental Probes	938	DHS/RS/RQ/108/20 date; 24/02/2021	Rivomed Holdings (pvt) ltd	Snaa Industries - pakistan	SPC Tender	Manufacturer registered with Indro (pvt) ltd. WOR Committee held on 11/06/2022 and committee decision was Not recommended and advised to register the product. Advised to NOL from Indro (Pvt) ltd.	Not recommended and advised to register the product.

20/08/2022

Date of Submission

NMRA Ref: Number

Item

Qty

Invoice / Tender Number

Invoice Value

Applicant

Manufacturer/ Supplier

Reason for WOR

Remarks

WOR Committee Approval

12/07/2022

MD/904/07/2022

Cryo Sure - DMSO, Dimethyl Sulfoxide 10x10ml vials

240

104994, date: 06/07/2022

EUR 2,232.00

Emar Pharma (Pvt) ltd

WAK-Chemie Medical GmbH-Germany

For National Blood Transfusion Service.

Manufacturer is not registered under NMRA.

Recommended only for this consignment. Advised to submit file.

12/07/2022

MD/905/07/2022

Cold Disinfectant for Haemodialysis Machine

777634582, date: 22/12/2021

EUR 480.50

Fresenius Medical Care

Fresenius Medical Care - Germany

For Lady Ridgway Hospital and Colombo East Base Hospital

File Submitted for registration and sample not provided for evaluation by local agent. (D/899)

Not recommended. Advised to provide samples to expedite registration.

12/07/2022

MD/907/07/2022

Spare Parts for Patient Monitors and Defibrillators

As per the invoice

10027214, date: 29/06/2022

USD 24,883.50

Hemas Surgical & Diagnostics

Nihon Kohden - Japan

For Sri Jayewardenepura Hospital

Agency transfer completed. But file not submitted by Hemas after agency transfer.

Recommended only for this consignment. Will not consider for WOR again. Advised to submit the dossier for registration.

12/07/2022

MD/908/07/2022

Spare Parts for Patient Monitors

As per the invoice

10027146, date: 29/06/2022

USD 3,017.48

Hemas Surgical & Diagnostics

Nihon Kohden - Japan

For District General Hospital - Trincomalee

Agency transfer completed. But file not submitted by Hemas after agency transfer.

Recommended only for this consignment. Advised to register the product for future importation.

12/07/2022

MD/909/07/2022

Respiratory Pathogen Panel Kit V-1.0

SORD-072837, date: 09/06/2022

LKR 1,068,360.16

Analytical Instruments

3B Black Bio Biotech Ltd - India

KDU Purchase Order

New Manufacturer. Manufacturer site is registered. (FMSA/MD/2021/85) But manufacturer name is different. Site is registered as Klipset India.

Not recommended and advised to register the product.

12/07/2022

MD/910/07/2022

HLA Reagents

As per the Invoice

7581939, date:16/06/2022

USD 125,586.07

Emar Pharma (Pvt) ltd

One Lamda Inc – USA

For National Blood Transfusion Service

File already submitted for registration.

(D/2731,D/3897)

D/2731 – evaluation completed. D/3897- Under end user evaluation BB)

Recommended only for this consignment. Expedite the registration.

12/07/2022

MD/911/07/2022

Intravenous or Arterial tubing administration set. Closed System Transfer Set

20 x 7 (140 Units)

C3001, date:7/7/2022

USD 2,100.00

Apcot Marketing (Pvt) ltd

BQ Plus Medical Co.ltd - China

For National Blood Transfusion Service and Asiri Central Hospital.

New Manufacturer.

Recommended only for this consignment. Advised to submit file.

15/07/2022

MD/912/07/2022

1)Epic Tissue Value(Brand : Epic, Model: E100 series)

2)Trifecta Tissue Value (Brand: Trifecta, Model: TFGT Series)

3)Value Graft Aortic Heart Value (Brand: SJM Masters Series, Model: CAVGJ Series)

CGZ/SJM/CSD/002/2022 date: 23/06/2022, CGZ/SJM/CSD/003/2022 date: 23/06/2022

USD 58454.00

Ceegeez Associates

M/s. St. Jude Medical – United States

For urgent patient treatments in government and private sector hospitals.

Already registered product and manufacturing site change. New manufacture in site registered on May 2022. (MD/160)

Recommended only for this consignment.

(New manufacturing site registration being proceed.)

15/07/2022

MD/913/07/2022TENS

TENS

(Model: XY-K-SJD-A)

(Muscular Stimulator)

As per the invoice

J20220222, date: 22/02/2022

USD

Rajini Jayathilaka

Xiangyu Medical Co.ltd - China

For Personal Use.

New Manufacturer.

Recommended only for this consignment.

19/07/2022

MD/916/07/2022

Dialysis Chairs

493, date:

19/04/202

Synergy Life Solutions (Pvt) ltd

Gardhen Bilance - Italy

For Lady Ridgway Hospital for Children and Lanka Hospital PLC.

· FR granted recently. (MDEC 3^rd August 2022. (D/1699)

Not recommended. Expedite the registration.

22/07/2022

MD/919/07/2022

Hair PRP Kits

400

N/A

Takara Entreprises

Beijing Manson Technology Co.ltd

For PRP Treatments.

Not Manufacturer.

Not recommended and advised to register the product.

26/07/2022

MD/920/07/2022

Reagents for immunoassay/ Architect Analyzer

As per the invoice

ADD/PF/A523/2022/PAK/GMBH, date: 14/07/2022

US $ 9548.00

Hemas Surgical & Diagnostics

Abbott GmbH - Germany

To meet urgent demand due to manufacturing site change

Already file submitted ( D/3476) and under processing. (P9)

Not recommended. Expedite the registration.

26/07/2022

MD/931/08/2022

A chromatographic immunoassay for the differential and qualitative detection of influenza virus A, B and A (H1N1) antigens directly from nasal/ throat/nasopharyngeal swabs or nasal/nasopharyngeal aspirate specimens.

375

20026632 / 20026633 / 20026634 / 20026635 / 20026636

Date: 07/07/2022

USD 6750.00+6750.00+6750.00+6750.00+6750.00..

George Steuart Health (pvt) ltd

Abbott Diagnostics Korea Inc - Korea

To various hospitals.

Manufacturer is registered with this local agent George Steuart for different products.

Not recommended and advised to register the product.

29/07/2022

MD/929/08/2022

Disinfection Cap (Stay Safe Disinfection Cap)

520

PI4503108906,date: 01/06/2022

EUR 46.80

Fresenius Medical Care Lanka (Pvt) ltd

Fresenius Medical Care AG & Co. KGaA - Germany

For Several government and Private Hospitals.

Registration Not recommended by Expert and requested Additional Documents. (D/2867)

Not recommended and advised to register the product. Please follow the advice of the end user mentioned in the evaluation report.

02/08/2022

MD/930/08/2022

1.Ortho Kit

2.Stethoscope

3.BP Monitors. (Brand:Omron, Elko)

250

649

200

PI/2122/83

USD 5739.26

Hemas Pharmaceuticals (Pvt) ltd

Omron Healthcare - Japan.

For Promotional Purpose.

(Free of Charge.)

New Manufacturer. Free of Charge Promotional Materials.

Pending Decision. Advised to submit NO Objection Letter from registered agent.

02/08/2022

MD/1005/08/2022

NovoSorb BTM – Dressing absorable

N/A

Technomedics International (Pvt) ltd

Polynovo Biomaterials pty ltd - Australia.

Donation.

Army hospital - Colombo and SBSCH - Peradeniya

Manufacturing site change completed. And sample license process.

Recommended only for this consignment.

02/08/2022

MD/1005/08/2022

Biomedical Freezer

HRP-004-Biomedica-2022, date: 27/7/2022

USD 3495.00

Biomedica (Pvt) ltd

Haier Biomedical Co.ltd - China

For University of Colombo.

Research purpose.

Grace period granted by MDEC until July 2023 for registration of freezers.

Recommended only for this consignment. Advised to register as listed medical device.

02/08/2022

MD/1007/08/2022

Thromboelastomy Reagents

45+20

PORD-000728, 17/05/2022

Eur 22,338.05

Surgicare (Pvt) ltd

TEM Innovations - Germany

Already registered product (D/888/RR) D/538) German origin product registered. Manufacturing site changed to Denmark – Finland)

Recommended only for this consignment.

08/08/2022

MD/1015/08/2022

Infusion Syringe Pump Including Software and Standard Accessories and Spare Parts

BBLK/INV/002/2022, date: 27/07/2022

EUR 2,193.22

B. Braun Lanka (Pvt) ltd

B. Braun Melsungen AG - Germany

Lanka Hospitals Purchase Order

Already registered product (DVR 882 RR). MF site changed and Submitted application and under processing

D/4160

Not recommended. Expedite the registration.

08/08/2022

MD/1016/08/2022

I.V. Administration Sets for chemotherapy.

2000

BBLK/INV/001/2022, date: 22/07/2022

EUR 5640.00

B. Braun Lanka (Pvt) ltd

B. Braun Melsungen AG - Germany

For Chemotherapy receiving pa tient.

Manufacturer registered with B Braun Lanka.

Not a registered product.

Recommended only for this consignment. Advised to submit registration dossier.

10/08/2022

MD/1017/08/2022

Plaster of Paris Bandage BP

50,000 rolls and 8,000 rolls

N/A

Swedish Trading Company (Pvt) ltd

Cotton Craft (Pvt) ltd - Pakistan

For Health System Enhancement Project, Ministry of Health.

Full registration expired on 2019. Not the apply for re registration. Sample license applied recently to submit new file.

Recommended only for this consignment. Expedite the registration.

10/08/2022

MD/1018/08/2022

Paraffin Gauze Dressing BP

35,000 rolls

N/A

Swedish Trading Company (Pvt) ltd

Cotton Craft (Pvt) ltd - Pakistan

For Health System Enhancement Project, Ministry of Health.

Registration expired on 2014. (DVR3701) Sample licenses applied.

Recommended only for this consignment.

10/08/2022

MD/1019/08/2022

Absorbent Cotton Wool BP

350,000 rolls

N/A

Swedish Trading Company (Pvt) ltd

Cotton Craft (Pvt) ltd - Pakistan

For Health System Enhancement Project, Ministry of Health.

FR expired on 2022. (DVR12699)

Recommended only for this consignment. Expedite the registration.

10/08/2022

MD/1020/08/2022

Absorbent Cotton Wool BP

15,000 rolls

N/A

Swedish Trading Company (Pvt) ltd

Cotton Craft (Pvt) ltd - Pakistan

For Health System Enhancement Project, Ministry of Health.

FR expired on 2022. (DVR12699)

Recommended only for this consignment. Expedite the registration.

10/08/2022

MD/1021/08/2022

Absorbent Cotton Wool BP

100,000 rolls

N/A

Swedish Trading Company (Pvt) ltd

Cotton Craft (Pvt) ltd - Pakistan

For Health System Enhancement Project, Ministry of Health.

FR expired on 2022. (DVR12699)

Recommended only for this consignment. Expedite the registration.

16/08/2022

MD/1030/08/2022

1. Blood Grouping Anti - A

2113272, date: 03/01/2022

58,950.7

Transmed Internatio nal (Pvt) ltd

Diagast -

France

For National

Transport

Medical Institute.

1. Registered product and registration expired in 2021. (File : DVR 13583) Local agent not applied to extend the registration.

Not recommended and advised to register the product.

2. Blood Grouping Anti – B

Same as above

2. Registered product and registration expired in 2021. (File : DVR 139223) Local agent not applied to extend the registration.

3. Blood Grouping Anti - D

Same as above

3. Registered product and registration expired in 2021. (File : DVR 13922) Local agent not applied to extend the registration.

16/08/2022

MD/1031/08/2022

Consumables for Stem Cell Harvesting Kits

380

TSL/SL/22/08/01, date: 5/8/2022

Euro 13,300.00

Apcot Marketing (Pvt) ltd

Maco Pharma Rue Lortgiois - France.

For National Blood Transfusion Service and Asiri Central Hospital.

Manufacturer already registered with NMRA.

Recommended only for this consignment. Advised to submit file for registration.

16/08/2022

MD/1032/08/2022

Disinfectant for Instruments and endoscopes. (brand: Getinge) (Universal Detergent 1x5L , Rinse Aid 1x5L)

200+60

8085412095, date: 25/07/2022

USD 11,620.00

Mediquipment Limited

Getting Disinfection AB - Sweden

For Central Hospital Limited and Hemas Thalawathugoda.

Manufacturer registered with NMRA.

Recommended only for this consignment. Advised to submit dossier for registration.

18/08/2022

MD/1033/08/2022

Reagents for Architect Clinical Chemistry Analyzer (Analyze(Brand: Abbott)

As per the invoice

5500014485 date: 28/07/2022

USD 34,376.00

Hemas Surgical and Diagnostics (Pvt) ltd

Abbott Laboratories - USA

For National Hospital of Sri Lanka.

Already registered (DVR 16055) and manufacturing site change. New file submitted and under processing. (File:D/4126)

Not recommended. Expedite the registration.

22/06/2022

MD/844/06/2022

Air Mettress (Brand: Fitconn, Model: FU-AM001)

2700

P22309JN151, date: 09/03/2022

US $ 38,905.00

Medica Pharmaceuticals (Pvt) ltd

Shenzhen Fitvonn Technology Co.ltd - China

to cover the shortage in Sri Lanka Market

Appeal.

Manufacture is not registered with NMRA. Registered sources available.

WOR Committee held on 13/07/2022 and committee decision was Not recommended and advised to register the product.

Not recommended and advised to register the product.

22/06/2022

MD/845/06/2022

Wheelchairs

328

HBDS2204297152, date: 2022/04/29

USD 16252.00

Medica Pharmaceuticals (Pvt) ltd

Hebei Dansong Medical Equipment Co.ltd - China

to cover the shortage in Sri Lanka Market

Appeal.

Manufacture is not registered with NMRA.

Registered sources available.

WOR Committee held on 13/07/2022 and committee decision was Not recommended and advised to register the product.

Not recommended and advised to register the product.

9/9/2021

MD/07/09/2021

Oxygen Production Plant, Generator (Oxymat - Slovakia)

Tender Number:UNOPS-22900-EPP-030R, date:02/09/2021

USD 1,570,000.00

Delmege Forsyth & Co.ltd

Process Engineering S.r.l - Milano

UNOPS Tender.

WOR Committee held on 13/07/2022 and committee decision was Pending Decision. Advised to send a letter Director (Building), Ministry of Health for evaluate the product.

Pending Decision. Referred to College of Anesthesiology.

25/04/2022

MD/748/04/2022

Oxygen Generator Plant

N/A

Delmege Forsyth& Co.ltd

Meditech TechnologyCorp.ltd-China

Ministry of Health Tender

Manufacturer not registered under NMRA. WOR Committee held on 07/05/2022 and committee decision was Currently NMRA not regulating Oxygen Generator Plant. If tender is awarded after BMES evaluation to issue NOL.

Pending Decision. Referred to College of Anesthesiology.

Date of Submission

NMRA Ref: Number

Item

Qty

Invoice / Tender Number

Invoice Value

Applicant

Manufacturer/ Supplier

Reason for WOR

Remarks

Previous WOR Committee Decision

WOR Committee Approval

15/06/2022

MD/831/06/2022

1. Main Stretcher

2. Foldaway Stretcher(for ford ambulances)

Future Automobiles (Pvt) ltd

Jiangsu Rixin Medical Equipment co.ltd - China

For Ministry of Health

(Not a Donation)

Manufacturer is registered under NMRA with Local Agent "Access international". (No current valid registrations for the product.)

ISO, EC certificates and registration document of US FDA are submitted.

WOR Committee held on 13/07/2022 and committee decision was Not recommended. Need a recommendation from college of anesthesiology. Advised to arrange an inspection with college members of

Anesthesiology.

Recommended only for this consignment.

Same as above

3. Portable Oxygen Therapy Kit

Same as above

Medbirlesim - Turkey

For Ministry of Health

(Not a Donation)

Manufacturer not registered

ISO, EC certificates are submitted.

Same as above

4. First Aid Bag (for ford ambulances)

Same as above

Medbirlesim - Turkey

For Ministry of Health

(Not a Donation)

Manufacturer not registered

ISO, EC certificates are submitted.

17/09/2021

MD/100/09/2021

Fingertip Pulse oximeter

100

1Z5582W46790642971

USD 340.00

N.P. Charith Chanuka Nugawela.

Dongguan Bucks Medical technology Co.ltd - China

BMES not recommended. Report of pending from anesthesiology

New Manufacturer.

Not recommended and advised to register the product.

20/08/2022 - S.P.C

Date of Submission

NMRA Ref: Number

Item

Qty

Invoice /

Tender Number

Invoice Value

Applicant

Manufacturer/ Supplier

Reason for WOR

Remarks

WOR Committee Approval

15/07/2022

MD/914/07/2022

Central Venous Catheter Set, Double Lumen and Triple Lumen

As per the invoice

DHS/ICL/X/RS/026/2022

date:31/03/2022

USD 68,006.00

Nextgen Healthcare

La-Med Healthcare (Pvt) ltd - India

SPC Tender

Manufacturer Registered with NMRA. Single Luman Catheter rejected by expert. (DVR/16986). Double Luman Catheter registration expired in 2019. (DVR/17287)

Not recommended. SPC informed enough stock is available.

19/07/2022

MD/915/07/2022

Extension Plaster BP

As per the invoice

DHS/ICL/X/RS/037/116AM/2022, date:13/06/2022

US $ 23,400.00

Intermediq Holdings (Pvt) ltd

Dr. Sabhanwals Wound Care - India

SPC Tender

Product was registered with Geekay and expired on 2016. (DVR/16070)

Recommended with Condition. Subject to submit of NOL from previous local agent, Geekay.

19/07/2022

MD/917/07/2022

Non Absorbable Monofilament Surgical Suture

21000

DHS/ICL/X/RS/013/128RA/22, date:28/06/2022

US $ 83,160.00

Synerg0.y Life Solutions (Pvt) ltd

Healthium Meditech Limited - India

SPC Tender

FR granted on November 2021
(D/590 RR).Recently Agency transfer to this local agent.

Recommended only for this consignment.

22/07/2022

MD/918/07/2022

Disposable Intravenous Solution Giving Sets for Single Use

900000

DHS/PS/171/2022

date:05/07/2022

US $ 95,400.00

Medica Pharmaceuticals

Hi-Tech Medics (Pvt) ltd - India

SPC Tender

Manufacturer earlier appointed shield Medical and manufacturing site still not registered with NMRA. Recently agency transfer is under processing from Shield medical to this Local agent.

Hold till SPC submit tender documents.

04/08/2022

MD/1004/08/2022

HBsAg Rapid Test (Brand: OnSite)

160 packs

LP/DHS/RL/18/33WAC/22, date:26/07/2022

LKR. 560,000/-

Quick Medical Diagnostics (Pvt) ltd

CTK Biotech Inc - USA

SPC Tender

FR granted recently (D/1314) Sub EMDEC 19/08/2022.

Not recommended. Expedite the registration.

08/08/2022

MD/1022/08/2022

Micro Motor System with Hand priece, Accessories, Spare Parts

LP/DHS/SUS/WW/187/403DS/21, date: 03/11/2021

LKR 35,700,000.00

A. Baur & Co. (Pvt) ltd

Medtronic Xomed Inc - USA.

SPC Tender

Already registered product (DVR 14474). Same legal manufacturer and Manufacturing site changed. File still not submitted.

Recommended only for this consignment.

16/08/2022

MD/1034/08/2022

Urine Collecting Bag -2000ml (Brand: Romsons)

35,000 + 500,000

DHS/S/WW/38/84KC/2021, date: 28/12/2020 , DHS/S/WW/38/434KC/2021, date: 3/8/21

USD 205,625.00+117,500.00

Lanka Laboratories (Pvt) ltd

M/s. Romsons International - India

SPC Tender

Already file submitted for submission. (D/3906) Awaiting evaluation by expert.

Recommended only for this consignment.

18/08/2022

MD/1035/08/2022

Temporary Anchorage Screw

2460

DHS/SUS/WW/181/553DR/2021, date:16/06/2022

USD 22,939.10

Med Solutions (Pvt) ltd

Osteonic Co.ltd - Korea

SPC Tender

Legal manufacturer registered with NMRA. In 2014 submitted file was referred to DDG Dental Service, Ministry of Health. Sent reminder but file not returned. (DVR-15150)

Not recommended. Considering the critical nature of the product, request to submit a new file.

08/10/2022

Date of Submission

NMRA Ref: Number

Item

Qty

Invoice / Tender Number

Invoice Value

Applicant

Manufacturer/ Supplier

Reason for WOR

Remarks

WOR Committee Approval

22/08/2022

MD/1051/09/2022

Surgical Kit

N/A

Oram (Pvt) ltd

M/s. Kamal Encon Industries Ltd - India

Usage of low income university student's practical sessions.

Manufacturer is not registered.

Not recommended and advised to register the product.

29/08/2022

MD/1055/09/2022

Vacum off pump system for cardiac surgical procedures (Brand: Acrobat-OM Series)

SEA-ACT-2022-002,

USD 25,000.00

Ceegeez Associates

Getinge AB - Sweden

For urgent patient treatments in government and private sector hospitals.

Registered product of manufacturer with ceegeez. (Ref No: DVR-11592)

Not recommended. Expedite the registration.

29/08/2022

MD/1056/09/2022

Reagents for Hematology Analyzer

1170 EA

10030052, date: 23/08/2022

USD 35,900.50

Hemas Surgical & Diagnostics

Nihon Kohden - Japan

For Sri Lanka Air Force

Manufacturer registered with Hemas Surgicals (Only for defibrillator)

Recommended only for this consignment. Advised to Expedite the registration process.

07/09/2022

MD/1062/09/2022

Dental Extraction Elevators

S20220608, date:08/09/2022 (DE 532)

USD$ 55.90

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

Not registered Manufacturer.

Pending Decision.

Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied.

07/09/2022

MD/1063/09/2022

Autoclave Sterilizer

S20220608, date:08/09/2022

USD$ 480.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

Not registered Manufacturer.

Pending Decision.

Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied.

07/09/2022

MD/1064/09/2022

Complete Dental Chair and Unit + Air Compressure

S20220608, date:08/09/2022

USD$ 4,730.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

Not registered Manufacturer.

Pending Decision.

Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied.

07/09/2022

MD/1065/09/2022

Physio Dispensor

S20220608, date:08/09/2022 (C-SAILOR)

USD $ 1,700.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

Not registered Manufacturer.

Pending Decision.

Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied.

07/09/2022

MD/1066/09/2022

Dental Light Luring Metchine

S20220608, date:08/09/2022 (LED-B)

USD$ 53.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

Not registered Manufacturer.

Pending Decision.

Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied.

07/09/2022

MD/1067/09/2022

SCS Extraction Forceps

S20220608, date:08/09/2022 (DE-255)

USD $ 50.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

Not registered Manufacturer.

Pending Decision.

Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied.

07/09/2022

MD/1068/09/2022

Dental Extraction Froceps

S20220608, date:08/09/2022 (DE-256)

USD $ 80.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

Not registered Manufacturer.

Pending Decision.

Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied.

07/09/2022

MD/1069/09/2022

Dental Extraction Froceps

S20220608, date:08/09/2022 (DE-254)

USD $ 75.00

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

Not registered Manufacturer.

Pending Decision.

Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied.

07/09/2022

MD/1070/09/2022

Dental Extraction Froceps

S20220608, date:08/09/2022 (DE-253

USD $ 97.50

Dr. Neil Hemantha Karandeniya

SCS Medical Instrument Ltd - China

For Surgery.

Not registered Manufacturer.

Pending Decision.

Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied.

07/09/2022

MD/1071/09/2022

PCS CRP rapid test kit, PCS FTN test Kits, PCS CTN test kits, PCS CRP test detection buffer

8+2+3+8

N/A

A.A. Jeyapragasam

M/s. Guangzhou Wondfo Biotech Co.ltd - China

For Abishaa Hospital (Pvt) ltd - Vavuniya

Manufacturer is registered under NMRA with, Lifeserv – HCG Strips.

- PC Pharma - Syphilis test.

- Sri Chin Holdings – HCG Strip.

Not recommended and advised to register the product.

02/09/2022

MD/1073/09/2022

Spare Parts for Video Endoscopy System

As per the invoice

PMSSPI0000000018859, date: 19/08/2022

USD 17,487.74

Biomed International (Pvt) ltd

Hoya Corporation - Japan

For Teaching Hospital - Anuradhapura, Base Hospital - Elpitiya, Teaching Hospital - Kuliyapitiya, Office of Regional Director of Health Services - Puttalam, Base Hospital - Homagama, District General Hospital - Hambantota, Hemas Hospital (Pvt) ltd

Registered Product. (Ref: D-980-RR)

Recommended only for this consignment.

09/09/2022

MD/1091/09/2022

Training Unit (TRN 3100), AED Unit and Spare Parts

1 x 4

10030343, date:05/09/2022

USD 1,727.00

Hemas Surgical & Duagnostics

Nihon Kohden - Japan

Donation to College of Anesthesiologists and Intensivists of Sri Lanka

Manufacturer registered with Hemas Only for this defibrillator.

Recommended only for this consignment.

09/09/2022

MD/1090/09/2022

10ml Syringe, 20ml Syringe and 60ml Syringe (Brand: Terumo)

30,000

PFI-22/009, date: 06/09/2022

USD 920.00

Hemas Surgical & Duagnostics

Yaoungzhou Medline Industry Co.ltd - China.

Donation to Sri Lanka College of Pediatricians

Yaoungzhou Medline Industry Co.ltd - China is not registered.

Recommended only for this consignment.

09/09/2022

MD/1093/09/2022

College of American Pathologist (CAP) Proiciency Testing Program

As per the invoice

384838 date: 31/07/2022

$83,727.00

Lanka Hospital Diagnostics (Pvt) ltd

College of American Pathologist - United Status of America

For External Quality Assurance Programme of the Lab.

Not a registered manufacturer.

Recommended only for this consignment.

16/09/2022

MD/1094/09/2022

Wallace Catheters & Oocyte recovery system (IUI Catheters, Surview Embray Replacement Catheter, Stylet, Oocyte recovery system)

400

OIPL/21-22/PI/AB/001, date: 22/08/2022

$41,966.30

A. Baur & Co. (Pvt) ltd

Cooper Surgical Inc - USA

For several Hospitals. (Lanka Hospital PLC, Nawaloka Hospital PLC, Vindana Reproductive Health Centre, Suwika Fertility Center, Ninewells Hospital & Asiri Hospitals)

Manufacturer is registered with Kanmed & Technomedics for different product. (Ref: DVR-10232/DVR-16435 /DVR-16804/ DVR-10233/DVR-10234.

New site to be registered.

Recommended only for this consignment.

16/09/2022

MD/1102/09/2022

Sterilizer System and standard accessories and spare parts (Brand:Getinge, Model:Solsus 66)

As per the invoice

8085412108, date: 29/07/2022

USD 101,431.00

Mediquipment Limited

MAQUET GmbH - Germany

For Leesons Hospital - Ragama.

Manufacturer registered with Technomedics & Swiss biogenics for different product.

Not recommended and advised to register the product.

16/09/2022

MD/1103/09/2022

Fetal/Maternal Monitoring Solution (CTG Machine) with Standard Accessories, Consumables and Spare parts (Brand: Toitu, Model: MT - 516)

As per the invoice

220905-10, date: 05/09/2022

Yen 1,095,000.00

Mediquipment Limited

Toitu Co.ltd - Japan

For Base Hospital - Elpitiya and B.H. Dehiaththakandiya.

Registered Product. (Ref:DVR-13556)

Recommended only for this consignment.

16/09/2022

MD/1104/09/2022

Sterilizer System and standard accessories and spare parts (Brand:Getinge, Model:HS66, HC)

As per the invoice

8085412258, date: 28/08/2022

USD 21,031.18

Mediquipment Limited

Getinge AB - Sweden

For Several Government and privet sector hospitals)

Registered manufacturer with Mediquipment Limited. (Ref: DVR-13130)

Recommended only for this consignment.

16/09/2022

MD/1106/09/2022

Upper Arm Electronic Blood Pressure Moitor (Brand:MG, Model: U80EH)

5000 Pack

CMS221024-1, date:24/07/2022

Euro 12,500.00

MG Medicals (Pvt) ltd

Shenzen Urion Technology Co.ltd - China

For Government Hospitals

Not a registered manufacturer under NMRA.

Not recommended. Expedite the registration.

12/09/2022

MD/1107/09/2022

Microscope (Brand: Xeiss, Model: Vario 700)

44113584, date: 19/07/2022

Euro 2,700.00

Qveensbury Hospitals (Pvt) ltd

Carl Zeiss AG - Germany

For Teaching Purpose

Manufacturer is registered with Dimo (Pvt) ltd

Pending Decision.

Advised to submit the Private Health Services Regulatory Council Registration Certificate and Evidence of Teaching activities related to this field of medical device.

15/09/2022

MD/1109/09/2022

Artificial Limbs

N/A

Matammana Orthopedic Suppliers Company (Pvt) lyd

N/A

No manufacturer details.

Product Categorization.

20/09/2022

MD/1111/09/2022

Infusion Pump Including Software and Standard Accessories and Spare Parts. (Brand: Infusion Space P, Volumetric)

1809703503, date: 09/09/2022

Eur 639.22

B. Braun Lanka (Pvt) ltd

B. Braun Melsungen AG - Germany

Already a registered product.

Recommended only for this consignment. Advised to apply for registration.

02/09/2022

MD/1074/09/2022

Thermal Cycler - PCR (Brand: Thermo Fisher, Model: Miniamp Plus, Simpliamp, Hula Sample Mixture)

As per the invoice

73895636 SO, date : 11.2.2022 / 73897700 SO, date: 22.02.2022 / 73900143 SO, date: 04/03/2022

USD 2,100.00 + USD 4,700.00 + USD 4,684.00

Analytical Instruments (Pvt) ltd

Thermo Fisher - USA

For research and Development Use only. (Several Government Istitute)

Thermo Fisher Scientific – USA registered with Delmege forsyth & Co.ltd.

Pending Decision.

Advised to submit Ethic Committee Approval Letters for the research of mentioned all the institutions.

2209/2022

MD/1117/09/2022

Sterilizer Stem and Spare parts, standard accessories (Getinge Steam Sterilizer)

8085412348, date: 14/09/2022

USD 541.36

Mediquipment Limited

Getinge Sourcing LLC - Singapore.

For UHKDU and Dr. Neville Fernando Teaching Hospital

Registered manufacturer with Mediquipment for "Getinge" Sterilizer. (Ref:DVR-13784)

Recommended only for this consignment.

20/09/2022

MD/1110/09/2022

Socket Adapters For P&O Workshop

As per the invoice

22-2101939, date: 02/06/2022

Euro 22,961.60

Ministry of Defence (Local Agent: M/s. Vertrin International

M/s. Wagner Polymertechick GmbH - germany

For Sri Lanka Army.

(Not a Donation)

Not a registered Manufacturer.

Product Categorization.

23/09/2022

MD/1127/10/2022

Powder for production of liquid bicarbonate concentrate for bicarbonate heamodialysis

20,000 PCE

4503184353 date: 20/09/2022

Eur 16,600.00

Fresenius Medical Care Lanka (Pvt) ltd

Fresenius Medical Care AG & Co. KGaA - Germany

For patient with chronic kindly disease.

Registered manufacturer under NNRA. Previously registered product as a medicine. (Ref: D/4178)

Not recommended. Expedite the registration.

05/10/2022

MD/1130/10/2022

Ultrasound Gastro Videoscope (Model: GF-UCT180)

N/A

Technomedics International (Pvt) ltd

Shirakawa Olympus Co.ltd - Japan

shop of the Sri Lanka Society of Gastroenterology.

Manufacturer site is registered with Mediquipment & Access International. (Ref: DVR-14601)

Recommended only for this consignment with condition. (Should be re-exported after the workshop)

05/10/2022

MD/1132/10/2022

HbAIC Rapid Quantitative test (Brand: Finecare)

As per the invoice

DC/4633/22-23, date: 17/09/2022

INR 20,000.00

Shahul Hameedas Avdul Malik

Guangzhou Wondfo Biotech Co.ltd - China

For Laboratory use.

Manufacturer exists in the database with a different site address. With Lifeserv(Pvt) ltd, PC Pharma (pvt) ltd, Sri Chin Holdings. (Ref:DVR-3831)

Not recommended and advised to re-export.

05/07/2022

Research Instruments Parts

As per the invoice

3977184, date: 03/06/2022

USD 3,331.73

Prof. Prasanna Galhena, Director, Institue of Biochemistry, Molecular Biology and Biotechnology, University of Colombo

Agilent Technologies - Singapore

For Research and Development Purpose.

Donation. WOR Committee held on 13/07/2022 and committee decision was Recommended with condition. Subject to submission of Ethic Committee Clearance Letter.

Recommended only for this consignment.

26/07/2022

MD/920/07/2022

Reagents for immunoassay/ Architect Analyzer

As per the invoice

ADD/PF/A523/2022/PAK/GMBH, date: 14/07/2022

US $ 9548.00

Hemas Surgical & Diagnostics

Abbott GmbH - Germany

To meet urgent demand due to manufacturing site change

Already file submitted (D/3476) and under processing. (P9) WOR Committee held on 20/08/2022 and committee decision was Not recommended. Expedite the registration.

Recommended only for this consignment.

18/08/2022

MD/1033/08/2022

Reagents for Architect Clinical Chemistry Analyzer (Analyze(Brand: Abbott)

As per the invoice

5500014485 date: 28/07/2022

USD 34,376.00

Hemas Surgical and Diagnostics (Pvt) ltd

Abbott Laboratories - USA

For National Hospital of Sri Lanka.

Already registered (DVR 16055) and manufacturing site change. New file submitted and under processing. (File:D/4126) WOR Committee held on 20/08/2022 and committee decision was Not recommended. Expedite the registration.

Recommended only for this consignment.

26/07/2022

MD/931/08/2022

375

20026632 / 20026633 / 20026634 / 20026635 / 20026636

Date: 07/07/2022

USD 6750.00+6750.00+6750.00+6750.00+6750.00..

George Steuart Health (pvt) ltd

Abbott Diagnostics Korea Inc - Korea

To various hospitals.

Manufacturer is registered with this local agent George Steuart for different products. WOR Committee held on 20/08/2022 and committee decision was Not recommended and advised to register the product.

Not recommended. Expedite the registration.

12/07/2022

MD/909/07/2022

Respiratory Pathogen Panel Kit V-1.0

SORD-072837, date: 09/06/2022

LKR 1,068,360.16

Analytical Instruments

3B Black Bio Biotech Ltd - India

KDU Purchase Order

New Manufacturer. Manufacturer site is registered. (FMSA/MD/2021/85) But manufacturer name is different. Site is registered as Klipset India. WOR Committee held on 20/08/2022 and committee decision was Not recommended and advised to register the product.

Not recommended. Expedite the registration.

16/08/2022

MD/1030/08/2022

1. Blood Grouping Anti - A

2113272, date: 03/01/2022

58,950.7

Transmed Internatio nal (Pvt) ltd

Diagast -

France

For National

Transport

Medical Institute.

Registered product and registration expired in 2021. (File : DVR 13583) Local agent not applied to extend the registration.

WOR Committee held on 20/08/2022 and committee decision was Not recommended and advised to register the product.

Recommended only for this consignment. Expedite the registration.

2. Blood Grouping Anti – B

Same as above

Registered product and registration expired in 2021. (File : DVR 139223) Local agent not applied to extend the registration.

3. Blood Grouping Anti - D

1440

Same as above

Registered product and registration expired in 2021. (File : DVR 13922) Local agent not applied to extend the registration.

23/02/2022

MD/625/02/2022

Table Mounted Retractor

Gilead Innovations

Mediflex Surgical Products - USA

For National Hospital - Sri Lanka

Appeal.

Ongoing Agency Transfer to Gilead, September 2022. (LO/1280)

Submitted to WOR Committee held on 12/03/2022 and committee decision was Not recommended and advised to register the product. WOR Committee held on 09/04/2022 and committee decision was Not recommended and advised to register the product.

Not recommended and advised to register the product.

08/10/2022 - S.P.C

Date of Submission

NMRA Ref: Number

Item

Qty

Invoice / Tender Number

Invoice Value

Applicant

Manufacturer/ Supplier

Reason for WOR

Remarks

WOR Committee Approval

29/08/2022

MD/1057/09/2022

Immunohistochemistry Reagents

519

DHS/L/WW/81/014RS/22

US$ 16,555.40

A & M Suhada Enterprises (Pvt) ltd

Agilent Technologies Singapore - Singapore / Agilent Technologies Inc - US

SPC Order

Manufacturer not registered under NMRA.

Not recommended. Expedite the registration.

29/08/2022

MD/1054/09/2022

Praffin Gauze Dressing BP

34,000 Rolls

DHS/S/WW/86/22, date:31/08/2021

USD 54,060.00

Swedish Trading Company (Pvt) ltd

Cotton Craft (Pvt) ltd - Pakistan

SPC Order

Manufacturer registered with this local agent under NMRA.

Not recommended and advised to register the product.

23/09/2022

MD/1128/10/2022

One step test for dengue NS 1Ag Kit

10,000 packs

DHS/ICL/X/RL/027/22, date: 07/07/2022

US$ 358,000.00

Siba Holdings (Pvt) ltd

Meril Diagnostics (Pvt) ltd - India

SPC Order

Registered Product.

(Ref: Nu: D-1085) Expired on 01/08/2020.

Not recommended. Advice to procure from registered source.

06/10/2022

MD/1135/10/2022

Leads & Sheath

900 NOS

DHS/M/SS/WW/4/565DP/2021, date: 12/07/2022

US $ 562,500.00

Medrac (pvt) ltd

Medtronic International Limited - Singapore

SPC Order

Registered manufacturer site with Medtrac (Pvt) ltd. (SIL 4785/01/2022)

Pending Decision. Advised to request the registration certificate include the accessories.

06/10/2022

MD/1136/10/2022

Leads & Sheath

600 NOS

DHS/M/SS/WW/5/573DP/2021, date: 20/07/2022

US $ 720,000.00

Medrac (Pvt) ltd

Medtronic International Limited - Singapore

SPC Order

Registered with Medtrac (Pvt) ltd for "Vitatron MRI Surescan" single chamber pacemaker. (Ref:D-3388) (SIL under processing)

Pending Decision. Advised to request the registration certificate include the accessories.

19/11/2022
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Approval
01	12/10/2022	MD/1164/10/2022	Surgical Suture (Brand:Haidike, Model: PGA,PGLA, PDO, NYLON, SILK, POLYSTER, POLYPROPHYLENE	792	221002SLS, date: 2/10/2022	$369.96	Rashi International Import Export (Pvt) ltd	Shandong Haidike Medical Products Co.ltd - China	Reason not mentioned.	Manufacturer not registered. Registered sources available.	Not recommended and advised to register the product.
02	12/10/2022	MD/1163/10/2022	Dental Chairs (Brand: Haiyue, Model: HY-803, HY-806, HY-C9A, HY-E60)	N/A	N/A	N/A	Rashi International Import Export (Pvt) ltd	Foshan Haiyue (HIROL) Medical Equipment Co.ltd - China	Reason not mentioned.	Manufacturer not registered. Registered sources available.	Not recommended and advised to register the product.
03	12/10/2022	MD/1162/10/2022	Curing Light Machine (Brand: Jerry, Model: JR-CL17, JR-CL37)	10	JR-A220928, date: 28/09/2022	$479.00	Rashi International Import Export (Pvt) ltd	Foshan Jerry Medical Apparatus Co.ltd - China	Reason not mentioned.	Manufacturer not registered. Registered sources available.	Not recommended and advised to register the product.
04	12/10/2022	MD/1161/10/2022	Dental Handpieces (Brand: Jinme, Model: J1/J1 Plus-Tu, M1-R/U-CA, M1-SH-A, Ying-Su-B2/M4, Ying-Tu-B2/M4	155	JMDZ20220921, date: 21/09/2022	USD 2885.00	Rashi International Import Export (Pvt) ltd	Guandgong Jinme Medical Technology Co.ltd - China	Reason not mentioned.	Manufacturer was registered with Rivomed Holdings (Pvt) ltd. Registration granted for these items on 07.10.2019. (D/2296) No agency transfer process instated up to now.	Not recommended and advised to register the product.
05	17/10/2022	MD/1159/10/2022	Thromboelastomy Reagents	As per the invoice	PORD-000730, date: 06/07/2022	EUR 11,756.39	Surgicare (Pvt) ltd	TEM Innovations - Germany	For TH - Kalubowila, National Hospital of Sri Lanka, TH - Peradeniya, Directorate of Army Medical Procurement Services	Product registered valid up to 30.01.2022.But not enough quality from Germany site manufacturer declared. Real site of above products are Switzerland and UK.	Not recommended. Expedite the registration. Advised to submit dossier for registration.
06	19/10/2022	MD/1172/10/2022	1. Catheter mount 2. Anesthesia Breading circuits	207 Carton (475 Pcs)	CRR224023, date: 29/07/2022	USD 500.00	Medilon Equipment (pvt) ltd	Shanoxing Carere Medical Appliance Co.ltd - China	For Clear the shipment.	- Manufacturer not registered with NMRA. - For Catheter mount, for registered supplier are available and one registered supplier available for breading circuit.	Not recommended and advised to register the product.
07	11/10/2022	MD/1174/10/2022	Blood Glucose Monitoring System with Standard Accessories/Blood Glucose Test Strips with or without Lancet (Brand: BG-PRO)	3300	PI220920-1, date: 20/09/2022	USD 7,200.00	George Steuart Health (Pvt) ltd	Wellan Tech Co.ltd - Taiwan	For the Market	Previous product (Major II Blood Glucose Monitoring System) discontinued by the manufacturer and the local agent decided to register a new product. File submitted for registration on September 2022. (D/4300, D/4301) (Allocated to P25)	Not recommended. Expedite the registration.
08	28/10/2022	MD/1180/11/2022	Spare Parts for Anesthesia Machine (Brand: GE Datex Ohmada)	75	HSKDD00082, date: 26/08/2022	USD 12,073/-	Biomed International (Pvt) ltd	Datex Ohmeda Inc - USA	For several government hospitals. (Colombo East Base Hospital, District General Hospital - Matara, Teaching Hospital - Auradapura)	Already registered product and full registration expired in June 2022. (DVR/16091) Manufacturer discontinued the product and requesting WOR to import Spare Parts)	Recommended only for this consignment.
09	28/10/2022	MD/1183/11/2022	Blood Glucose Test Strips (Brand: One Touch Select Plus Test Strips)	22,000	272716, date: 19/10/2022	USD 76,241.00	Sunshine Healthcare	LifeScan Europe GmbH - Switzerland	To prevent the Out of stock situation in the market.	File submitted on September 2022 under processing. (D/4331 - Allocated to P42)	Not recommended. Expedite the Registration.
10	28/10/2022	MD/1187/11/2022	Spare Parts of Defibrillators	As per the Invoice	LDA03072022, date: 07/03/2022	$16,439.76	Hemas Surgicals & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Suwasariya 1990	Requesting WOR for Spare parts od already installed Defibrillators. (Model: Lifeline Aed) Agency transfer letter relevant to this model not attached with a request by Hemas.	Recommended only for this consignment.
11	28/10/2022	MD/1188/11/2022	Spare Parts of Patient Monitors	As per the Invoice	10031921, date: 18/10/2022	USD 50,605.29	Hemas Surgicals & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Teaching Hospital - Batticaloa	New manufacturing site. Manufacturing site still not registered and NMRA requested additional data for a registration. (FMSA/MD/2026)	Recommended only for this consignment.
12	28/10/2022	MD/1189/11/2022	Spare Parts of Patient Monitors	44	10031735, date: 18/10/2022	USD 5,808.46	Hemas Surgicals & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For China-Sri Lanka Friendship National Nephrology Specialized Hospital - Polonnaruwa	New manufacturing site. Manufacturing site still not registered and NMRA requested additional data for a registration. (FMSA/MD/2026)	Recommended only for this consignment.
13	28/10/2022	MD/1190/11/2022	Standard Accessories for Sterilizer Stem and Spare Parts (Getinge Steam Sterilizer)	As Per the Invoice	8085412503, date: 13/10/2022	USD 17,100.16	Mediquipment Limited	Getinge Sterilization AB - Sweden	For Mahaoya Base Hospital	Registration expired on 2019 and product discontinued by the manufacturer. (DVR/11509) Requesting WOR for Repairing the stream sterilizer at Mahaoya Base Hospital)	Recommended only for this consignment.
14	28/10/2022	MD/1191/11/2022	Antibacterial Wound Dressing with Copper	500	EI228000048, date: 18/08/2022	USD 1,340.00	E & H Holdongs Lanka (Pvt) ltd	MEDCU Technologies Ltd - Israel		Manufacturing site registered in November 2022. (FMSA/MD/2021/46) File still not submitting for register the product.	Not recommended and advised to register the product.
15	10/11/2022	MD/1204/11/2022	Heamostasis Introducer (Introducer Sheath)	600	20220906004, date: 06/09/2022	USD 12,150.00	Kish International (Pvt) ltd	APT Medical Inc - China		File submitted for registration on April 2022. Under processing. (D/4052 - Allocated to P39)	Not recommended. Expedite the registration.
16	08/11/2022	MD/1205/11/2022	Powder for production of Liquid Bicarbonate Concentrator for Bicarbonate Haemodialysis (Bibag 5008)	20,000 PCE	4503184353 date: 20/09/2022	EUR 16,600.00	Fresenius Medical Care Lanka (Pvt) Ltd	Fresenius Medical Care AG & Co. KGaA - Germany	For Haemodialysis Treatments	Product earlier registered under medicine. New file D/4178 submitted in June 2022 to register as Medical Device. (Allocated to P47)	Not recommended. Expedite the registration.
17	15/11/2022	MD/1207/11/2022	Pharmacy Refrigerator (Brand: Haier, Mode: HYC-310)	560	HRP-005-Biomedica-2022, date:03/11/2022	USD 1,320.00	Biomedica (Pvt) ltd	Haier Biomedical Co.ltd - China	For DDHS - Galle	Grace period given for registration of Pharmacy Refrigerator until June 2023 by NDEC.	Recommended only for this consignment.
18	15/11/2022	MD/1208/11/2022	Hydrophobic Acrylic Intraocular Lens	1000	3086, date: 17/10/2022	USD $ 45,800.00	Platinum Healthcare (Pvt) ltd	USIOL from Lexington - USA		New Manufacturer.	Not recommended and advised to register the product.
19	15/11/2022	MD/1209/11/2022	Dental Chair and Accessories Related to Dental Work	1	MS-20221008, date: 08/10/2022	USD 2550.00	Polwaththa Rathubadhuge Dilusha Jayani (Dental Surgeon)	Chengdu Maisheng Medical Equipment Corporate Limited - China	Use for Private Dental Clinic - Matara.	New Manufacturer. Requesting WOR for import one unit by a dental surgeon Dr. Dilusha Jayani.	Recommended only for this consignment. Advised to submit English Documents for your request. (Business License, Medical Device Certificate, Test report and ISO Certificate)
20	15/11/2022	MD/1210/11/2022	Immunohistochemistry Reagents	4	311348984, date: 01/09/2022	USD 2552.84	A & M Suhada Enterprises (Pvft) ltd	Agilent Technologies Singapore (International) Pte Ltd - Singapore.	For Medical Research Institute.	Manufacturer registered with NMRA and Sample import License granted recently.	Recommended only for this consignment.
21	08/11/2022	MD/1211/11/2022	E.C.G. Recording Paper	14,500 Rolls	EP/CC/02-2022, date: 12/10/2022	USD 4735.00	Emar Pharma (Pvt) ltd	M/s. Chhenna Corporation - India	For Several Private Institute	Full registration expired in March 2022. (DVR/16850) and delay submission of re-registration on September 2022. (D/4292, Allocated to P47)	Recommended only for this consignment.
22	08/11/2022	MD/1212/11/2022	Warming Solution Sets and Cryotec	20 + 100	22092302, date: 23/09/2022	Yen 1,545,000.00	Vindana Reproductive Health Centre (Pvt) ltd	Reprolife Inc - Japan	For In-vitro fertilization (IVF) treatment Services.		Recommended only for this consignment.
23	08/11/2022	MD/1213/11/2022	Assy, four button foot pedal Wireless (Brand: Whitestar Signature PRO)	1	94959, date: 27/10/2022	USD 9950.90	Hemas Pharmaceuticals (Pvt) ltd	Johnson & Johnson Surgical Vision Inc - USA	For Whitestar Signature PRO System	Accessories for already registered Phacoemulsification Stem. (D/1904) And this item is not included in the existing annexure list.	Recommended only for this consignment.
24	08/11/2022	MD/1214/11/2022	Tennis & Golf Elbow Wrap and others	As per the invoice	OP01-202210014, date: 20/10/2022	USD 91326.79	Hemas Surgical & Diagnostics (Pvt) ltd	OPPO Medical Corporation - Taiwan		Already registered product and agency transfer to Hemas. Due to manufacturing site changed, New site registered in July 2022 and Sample license applied in September 2022.	Recommended only for this consignment.
25	08/11/2022	MD/1215/11/2022	Knee Support and others	As per the invoice	P01-202210006, date: 06/10/2022	USD 345,349.67	Hemas Surgical & Diagnostics (Pvt) ltd	OPPO Medical Corporation - Taiwan		Already registered product and agency transfer to Hemas. Due to manufacturing site changed, New site registered in July 2022 and Sample license applied in September 2022.	Recommended only for this consignment.
26	08/11/2022	MD/1216/11/2022	Thinkpulse Active Electrode Kits for Academic Purpose	2	D2394, date: 29/07/2022	USD 349.99	Dr. M.S. Wickramasinghe, Senior Lecturer, Department of Computer Engineering, Faculty of Engineering, University of Peradeniya	Conscious Labs - France	For Research Purpose.		Recommended only for this consignment.
27	09/11/2022	MD/1218/11/2022	Bracytherapy Training Simulator for Cervial Cancer	1	ME-010-7-2210, date: 28/10/2022	JPY 385,000	Ministry of Health	Chiyoda technol Corporation - Tokyo	For Strengthening Cancer Management Programmes.		Recommended only for this consignment.
28	12/09/2022	MD/1107/09/2022	Microscope (Brand: Xeiss, Model: Vario 700)	1	44113584, date: 19/07/2022	Euro 2,700.00	Queensbury Hospitals (Pvt) ltd	Carl Zeiss AG - Germany	For Teaching Purpose	Manufacturer is registered with Dimo (Pvt) ltd. Submitted to WOR Committee held on 08/10/2022 and Decision was Pending. Advised to submit the Private Health Services Regulatory Council Registration Certificate and Evidence of Teaching activities related to this field of medical device.	Recommended only for this consignment.

19/11/2022 - S.P.C
No	Date of Submission	NMRA Ref: Number	Item	Qty	Invoice / Tender Number	Invoice Value	Applicant	Manufacturer/ Supplier	Reason for WOR	Remarks	WOR Committee Approval
01	17/10/2022	MD/1155/10/2022	DNA Whole Blood Kits	54 Kits	LP/DHS/LB/DQ/03/45SM/20, date: 13/12/2019	LKR 1,863,000.00	Emar Pharma (Pvt) ltd	RBC Bioscience Corp. - Taiwan	SPC Tender	File not submitted for registration.	Recommended only for this consignment.
02	19/10/2022	MD/1167/10/2022	Sodium Perborate Monohydrate 50% Powder Mix	45,000L	DHS/P/WW/284/22, date: 2/6/2022	USD 4,963.00	abcpharma	Sirmaxo Chemicals (Pvt) ltd	SPC Tender	BWD. 04.01.2017. Circular No: P-01/02/2017. Bath withdraw Due to more complaint from different institutions. New local agent has submitted new dossier for registration. (D/4341, evaluation)	Not recommended. Expedite the registration. (Product dossier in evaluation stage by Microbiology)
03	20/10/2022	MD/1168/10/2022	Re-usable Instruments for ENT surgery (Antral Trocar - Article no EJ316R, Tongue Despressor - Article no OM205R, Nasal Antrum Cannula - Article no OK874C, Nasal Antrum Cannula - Article no OK877R)	07+625+15+13	DHS/S/WW/44/748AK/21	USD 4890.82	B Braun Lanka	Aesculap AG - Germany	SPC Tender	Manufacturer registered with this local agent. Registered Source available.	Not recommended and advised to register the product. (Advised to submit the dossier for registration at NMRA or purchase from the registered supplier.)
04	25/10/2022	MD/1175/10/2022	Heat and Moisture Exchange Filter (Brand: Sterimed, odel: Adult/Pediatric)	Adults - 237,500 , Pediatric - 31,250	DHS/M/S/WW/14/21, date: 03/10/2022	USD 5,313.00 , 625.00	Sunshine Healthcare	Sterimed Surgicals India (Pvt) ltd - India	SPC Tender	- - Manufacturer registered with NMRA. - - Submission of Sample import license reference nu not mentioned in the request and according to NMRA Sample import license database, only applied Sample Import License for ET tube and Foley catheter.	Not recommended. Advised to submit the file for registration. (Tender not awarded so far. Advised NMRA to expedite if submit file for registration)
05	25/10/2022	MD/1176/10/2022 (MD/1135/10/2022)	Pacing Lead (Brand: Medtronic, Model: 5076) , Rercutaneous Lead Introducer (Brand: Medronic, Model: 6207)	900 NOS	DHS/M/SS/WW/4/565DP/2021, date: 12/07/2022	US $ 562,500.00	Medrac (Pvt) ltd	Medtronic Inc - USA	SPC Tender	Registered manufacturer site with Medtrac (Pvt) ltd. (SIL 4785/01/2022) Submitted to WOR Committee held on 08/10/2022 and Decision was Pending. Advised to request the registration certificate include the accessories.	Not recommended. Expedite the registration. Advised to request the registration certificate include the accessories.
06	25/10/2022	MD/1177/10/2022 (MD/1136/10/2022)	Rercutaneous Lead Introducer (Brand: Medtronic, Model: 6207, 6209) , Facing Lead (Brand: Medtronic, Model: 5076, 6935M)	720 NOS	DHS/M/SS/WW/5/573DP/2021, date: 22/07/2022	US $ 1,134,000.00	Medrac (Pvt) ltd	Medtronic Inc - USA	SPC Tender	Registered with Medtrac (Pvt) ltd for "Vitatron MRI Surescan" single chamber pacemaker. (Ref:D-3388) (SIL under processing)	Not recommended. Expedite the registration. Advised to request the registration certificate include the accessories.
07	15/11/2022	MD/1217/11/2022	Immunohistochemistry Reagents	58	DHS/RL/62/24SSN/2021, date: 11/10/2022	USD 33,968.00	A & M Suhada Enterprises (Pvft) ltd	Agilent Technologies Singapore (International) Pte Ltd - Singapore.	SPC Tender	For SPC Supply. Manufacturer registered with NMRA and Sample import License granted recently.	Recommended only for this consignment.

Waiver of Registration Committee - Device (January 2022 to June 2022)

Waiver of Registration Committee - Device (January 2022 to June 2022)

08/01/2022

Date of Submission

NMRA Ref: Number

Item

Qty

Applicant

Manufacturer/Supplier

Reason for WOR

WOR Committee Decision

16/12/2021

MD/434/12/2021

EMV+731 Series Ventilator with Standard Accessories & Spare Parts

Diligence Healthcare (Pvt) ltd

Zoll Medical Corporation - USA

Donation to Ministry of Health

Recommended only for this consignment.

16/12/2021

MD/435/12/2021

Ventilator Spare Parts

Diligence Healthcare (Pvt) ltd

Zoll Medical Corporation – USA.

Donation to Ministry of Health

Recommended only for this consignment.

16/12/2021

MD/445/12/2021

Electric Wheel Chair

Melson Camild Fernando

Ningbo Baichen Medical Devices Co.ltd - China

For Personal use.

Recommended only for this consignment.

11/11/2021

MD/453/12/2021

Horse Serum

Sri Lanka Standards Institution

For Sri Lanka Standers Institution

Recommended only for this consignment.

20/12/2021

MD/455/12/2021

ELISA Kits

Shani Weerasekara, Insitute of Indigenous Medicines, Uniersity of Colombo, Rajagiriya.

ElabScience Biotechnology Inc - USA

For Research Purpose. (To complete Master of Philosophy (Mphil) Degree at Facalty of Graduate Studies, University of Kelaniya)

Recommended only for this consignment.

17/12/2021

MD/456/12/2021

Covid 19 Antigen Lateral Flow Test Device OTC Home Test

Apcot Marketing (Pvt) Ltd

M/S Mylab Discovery Solutions Pvt. Ltd - India

Not recommended and advised to register the product.

20/12/2021

MD/458/12/2021

Oxygen Concentrator (5l)

G. Muthumala Motor Stores Colombo (pvt) ltd

Only one unit for personal use.

Recommended only for this consignment. Only to be used for said purpose and not for commercial purpose.

22/12/2021

MD/471/12/2021

Surgical Mask/Shoe Cover/Head Cap

180,000

Basilur Tea Export (Pvt) ltd

Nanjing Kaihong Healthcare Co. - China

Recommended. WOR Only for Shoe Cover and Head Cap. WOR not recommended for surgical mask.

22/12/2021

MD/474/12/2021

Medical Equipments

Sri Lanka Army

M/S Ottobock SE & Co.KGaA - Germany

For Army

Recommended only for this consignment.

24/12/2021

MD/489/12/2021

Electric Saw

Co-op Hospital - Eravur

Wuhu Ruijin Instrument & Device Co.ltd - China

Not recommended and advised to register the product.

24/12/2021

MD/478/12/2021

Ventilator Spare Parts

Diligence Healthcare (Pvt) ltd

Zoll Medical Corporation - USA

Recommended only for this consignment.

24/12/2021

MD/488/12/2021

Portable Stretchers

Korean Lanka Holding

Zhangjiangang Hishesee Co.ltd - China

For Chief Mechanical Engineering Office, Sri Lanka Railways, Rathmalana.

Recommended only for this consignment and advice to register as class I medical device.

24/12/2021

MD/477/12/2021

Gene Xpert Xpres-Sars-Cov-2

Analytical Instruments (Pvt) ltd

Cepheid - France

For WHO

WOR Not Recommended. Expedite the registration process.

24/12/2021

MD/482/12/2021

Spare Parts for Sterilizer System

Mediquipment Limited

Getinge Sterilization AB - Sweden

Repaired Item

Recommended only for this consignment.

24/12/2021

MD/483/12/2021

IHC Reagents

A & M Suhanda Enterprises (Pvt) ltd

Agilent Technologies - Sinapore

Recommended only for this consignment.

24/12/2021

MD/485/12/2021

Thromboelastomy Reagents

Surgicare (Pvt) ltd

TEM Innovations - Germany

Not Recommended and advised to purchase from the registered Manufacturer.

24/12/2021

MD/481/12/2021

Spare Parts for Ultrasound Diagnostic System

Biomed International (Pvt) Ltd

GE Medical Systems Co. ltd - China

For Teaching Hospital - kandy

WOR Not Recommended. Amend the certificate to include accessory list.

24/12/2021

MD/480/12/2021

Multi-Drug 6 Drugs Test Cup with Indicator (Saliva) (CE)

5,000

Divasa Pharma Ltd

Hangzhou Biotest Biotech Co.ltd - China

For National Dangerous Drugs Control Board. (Already have site registration)

Recommended only for this consignment.

04/01/20222

MD/498/01/2022

Hospital Beds and Equipments

U.P.S. Rodrigo

Lak Saviya Foundation - Australia

Donation from Laksaviya Foundation – Australia to several government institution.

Recommended only for this consignment.

30/12/2021

MD/504/01/2022

Ultrasound Spare Parts

Biomed International (Pvt) Ltd

GE medical Systems Co.ltd - China

For National Hospital in Sri Lanka (NHSL)

Not recommended to issue WOR. Advised to amend the certificate to include accessory and spare parts list.

31/12/2021

MD/511/01/2022

Oppo Orthopedic

43,725

Hemas Surgicals & Diagnostics (Pvt) ltd

Plus Meditech Co.ltd - Taiwan

Recommended only for this consignment.

31/12/2021

MD/497/01/2022

Orafil G (100 Packs)

100 (Packs)

Yu and Company (Pvt) ltd

Prevest Denpro Ltd - India

Recommended only for this consignment.

31/12/2021

MD/501/01/2022

Smart bag 211.50

Fresenius Medical Care

Fresenius Medical Care - Germany

Recommended only for this consignment.

17/09/2021

MD/125/09/2021

Pulse Oximeter (P-01, P-05)

2,000

Wintech Cellukar Services,

Shenzhen Jiangnan Medical Technology Co.ltd - China

For Covid 19 Pandemic Situation in Sri Lanka

Not recommended. Due to unsatisfactory clinical performance.

8/9/2021

Pulse Oximeter (Model - YK 81C)

10000

Research Instrunment Pvt ltd

Xuzhou Yongkang Electronic Science Technology Co.ltd - China

Recommended only for this consignment. (Only 5000 units)

17/09/2021

MD/128/09/2021

Pulse Oximeter (OX-02)

300

P. Amila Rangana Nonis

Shenzhen Tablet Electronics ltd - China

WOR Not recommended and advised to re-export. Due to unsatisfactory clinical and technical performance.

6/10/2021

MD/225/10/2021

Fingertip Pulse Oximeter (Model: YK-81B)

1,000

Taprobana Island (pvt) ltd

Xuzhou Yongkang Electronic Science Technology Co.ltd - China

Recommended only for this consignment.

6/10/2021

MD/226/10/2021

Fingertip Pulse Oximeter (Model: YK-80B)

2,000

Taprobana Island (pvt) ltd

Xuzhou Yongkang Electronic Science Technology Co.ltd - China

Not recommended and advised to re-export. Due to unsatisfactory clinical and technical performance.

9/9/2021

Pulse Oximeter (Model-YBM 303)

Vikum Shaminda,

Henan Yobekan Medical Equipment Co. ltd - China

Personal Use

Not recommended and advised to re-export. Due to unsatisfactory clinical performance.

17/09/2021

MD/123/09/2021

Fingertip Pulse Oximeter (YK-81C)

20,000

One Legacy (pvt) ltd

Xuzhou Yongkang Electronic Science Technology Co.ltd - China

For Governmental, Private Medical Institutions and Local Pharmacies

Recommended only for this consignment.

17/09/2021

MD/126/09/2021

Pulse Oximeter (YM102)

200

Devro International

Shenzhen Yimi Life Technology Co.ltd - China

Not recommended and advised to re-export. Due to unsatisfactory clinical performance.

9/9/2021

Pulse Oximeter (Model-P01)

100

M.H.M. Sharaf Deen

Shenzhen Jiangnon Medical Technology Co.ltd - China

Not recommended and advised to re-export. Due to unsatisfactory clinical and technical performance.

6/10/2021

MD/223/10/2021

Fingertip Pulse Oximeter (Model:MD300CN310)

250

D & W Associates International (Pvt) ltd

Beijing Choice Electronic Technoly Co.ltd - China

Recommended only for this consignment.

8/9/2021

Fingertip Pulse Oximeter (Model : C101 H1)

10000

E Friends

Shenzhen IMDK Medical Technology Co.ltd - China

Not recommended and advised to re-export. Due to unsatisfactory clinical performance.

17/09/2021

MD/106/09/2021

Pulse Oximeter

500

Clinivex (Pvt) ltd

Shenzhen Gemeitong Technology Co.ltd - China

For Personal Use, mainly for their own Staff and client with whom their associate frequently.

Not recommended and advised to re-export. Due to unsatisfactory clinical and technical performance.

17/09/2021

MD/99/09/2021

Fingertip Pulse Oximeter (YXY018A)

100

Sandun Lahiru Kulathilaka

Shenzhen E-Champion Technology Co.ltd - China

Not recommended and advised to re-export. Due to unsatisfactory clinical and technical performance.

10/12/2021

MD/431/12/2021

Lactate Analyzer

Sui Generis (pvt) ltd

Apex Biotechnology Co - Taiwan

For Institute of Sport Medicine

Not recommended. Advised to re-export and purchase from registered source.

3/11/2021

MD/326/11/2021

Five Function Electrical Bed and Other Medical Equipments

108

Kanola Hospital

Jiangsu Saikang Medical Co.ltd - China

For Kanola Hospital

Not Recommended. Advised to order from registered source.

6/11/2021

MD/199/10/2022

Tissue Vault, Cell Tissue Freezing Bag - All Size

Dowell International (Pvt) ltd

Origen Biomedical Inc - USA

For Lady Ridgway Hospital

Recommended only for this consignment.

14/09/2021

MD/81/09/2021

Fingertip Pulse Oximeter (LK87)

15000

Best Way Logistics (Pvt) ltd

Shenzhen Linke Technology Co.ltd - China

For Sales

Not recommended and advised to re-export. Due to unsatisfaction clinical and technical performance.

17/09/2021

MD/112/09/2021

Fingertip Pulse Oximeter

100

K.B.A Chamara Prabath

Sichuan Fu Yousi Co.ltd - China

Not recommended and advised to re-export. Due to unsatisfaction clinical and technical performance.

6/10/2021

MD/219/10/2021

Hydraguard + Antimicrobial Nano Coating

Junaht International (pvt) ltd

Safespaceinnovations(pvt) ltd - India

For Private and Government Sector

WOR Not recommended. Advised to submit more applied research evidence on the efficacy, performance and data on traceability, evidence of the use of the said product in other countries.

7/1/2022

MD/513/01/2022

N95 Masks

UNOPS - Sri Lanka.

Makrite Industries Inc / Dongguan Sure_On Plastic & Fiber Products Co.ltd - China

For MOH

Recommended only for this consignment.

7/1/2022

MD/514/01/2022

Hospital Beds / Wheel Chairs

68 + 08

Shraddha Charity Organization

For Government Institute

Forwarded to CEO for necessary action.

7/1/2022

MD/515/01/2022

Hospital Beds

Rohini Chandra Fernando

For Apeksha Hospital- Maharagama (Donate from Australia)

Forwarded to CEO for necessary action.

7/1/2022

MD/516/01/2022

Test Strips for Blood Glucose Monitoring System (MEGACHECK)

12,000

Mega Meditech (Pvt) ltd

TaiDoc Technology Coroparation Wugu Factory - Taiwan

Not Recommended. Advised to request for extension of existing registration certificate. (FR)

5/1/2022

MD/517/01/2022

Ovulation Test Kits

Mariam Omar

For Personal Use

Not Recommended. Advised due to inadequate documents.

5/1/2022

MD/518/01/2022

Surgical Blades

100,000

Hayleys Agro Biotech (Pvt) ltd

For Sri Lanka Export Development Board

Not Recommended. (Purchase from registered source)

5/1/2022

MD/519/01/2022

Panthera C2 Trinocular 50: 50 / 0.4X C-mount camera adapter / BMH1080-U / SMZ171-TLED / 2.0X Objective for SMZ161/SMZ171 / 0.4X C-mount camera adapter

3 + 3 + 3 + 3 + 3 + 3

Anti-Malaria Campaign

World Health Organization

For Anti Malaria Campaign

Not Under NMRA Preview. (Product Categorization)

8/1/2022

MD/520/01/2022

Syringe Pump for Fluid Management /Including Software with standard Accessories & Spare Parts

550

Akbar Pharmaceuti cals (Pvt) Ltd

Smith Medical Instruments Co.ltd - China

Not recommended. As agency transfer letter not available.

8/1/2022

MD/521/01/2022

Wheel Chair

100

Sahana Sarana Social Welfare Foundation

Donation

Recommended only for this consignment.

8/1/2022

MD/522/01/2022

DENTSPLY Millefleur Protaper

Dr. Janaka Abeywardhana

Recommended only for this consignment.

8/1/2022

MD/524/01/2022

Disable Wheel Chair

Unique Tools and Machineries (Pvt) ltd

Dongguan Yattll Industry Co.ltd - China

Commercial Purpose

Not recommended and advised to register the product.

8/1/2022

MD/525/01/2022

Artificial Limbs Kits

Colombo Friend in Need Society

Recommended only for this consignment.

8/1/2022

MD/527/01/2022

Spirometer with Standard Accessories & Spare Parts (Vitalograph - 2120 Inzitive)

Delmege Forsyth & Co. ltd

Vitalograph (Irelan) ltd

For En Project - Kalutara District Specialized Maternal & Children Hospital.

Not Recommended issuing WOR. Advised to use Sample Import License and register the product.

8/1/2022

MD/528/01/2022

Urine Drainage Catheter

159

R & D Intertrades (PTE) Limited

Devon Innovations Pvt ltd - India

Not Recommended and advised to register the product.

8/1/2022

MD/526/01/2022

Face Masks

Ministry of Highways (Wang Fuwen)

Recommended only for this consignment. In future need to be purchased from local manufacturer.

08/01/2022 - S.P.C

Date of Submission

NMRA Ref: Number

Item

Qty

Applicant

Manufacturer/Supplier

Reason for WOR

WOR Committee Approval

16/12/2021

MD/442/12/2021

Anti A Series, Anti B , Anti A,B, Anti D and Others

Premium International (Pvt) ltd

Immucor Inc - USA

SPC Order

Recommended only for this consignment.

16/12/2021

MD/443/12/2021

Theraputic Plasma Exchange Kits (TPE Kits)

2,400

Premium International (Pvt) ltd

Fresenius Kubi - India

SPC Order

Recommended only fort his consignment.

22/12/2021

MD/475/12/2021

Laboratory Consumables

SPC (A&M Suhada 69Enterprises (Pvt) ltd

M/s Agilent Technologies Denmark Aps - Denmark / USA

SPC Order

Recommended only for this consignment.

24/12/2021

MD/486/12/2021

Tissue Embedding Cassettes

514,000

Rivomed Holdings (Pvt) ltd

Ningbo Foyomed Medical Instrument (Pvt) ltd - China

SPC Order

Not recommended and advised to register the product.

24/12/2021

MD/487/12/2021

Biopsy Embedding Cassettes

334,000

Rivomed Holdings (Pvt) ltd

Ningbo Foyomed Medical Instrument (Pvt) ltd - China

SPC Order

Not recommended and advised to register the product.

24/12/2021

MD/479/12/2021

Arterial Leader Cath

tmi Solution (Pvt) ltd

M/S Vygon S.A - France

SPC Order

Recommended. Extend the already issued WOR.

24/12/2021

MD/484/12/2021

Immunohistochemistry Reagents

A & M Suhanda Enterprises (Pvt) ltd

Agilent Technologies - Sinapore

SPC Order

Recommended only for this consignment and expedite the registration.

18/08/2021

MD/494/12/2021

Talc Powder Sterile 4g Bottle

Instrumedic International (Pvt) ltd

M/s. Novatech SA - France

Submitted to WOR Committee held on 28/10/2021 and Committee Decision was Not Recommended and advised to register the product. SPC tender dossier not submitted.

Recommended only for this consignment.

7/12/2021

MD/426/12/2021

Dental Instruments

611

Rivomed Holdings (Pvt) ltd

ASA Dental S.P.A - Italy

Submitted to WOR Committee held on 11/12/2021 and Committee Decision was Not Recommended and advised SPC to bring their technical evaluation file.

Recommended only for this consignment.

8/1/2022

MD/523/01/2022

Sodium Bicarbonate Powder for Heamodialysis

5,376

Fresenius Medical Care

Fresenius Medical Care - Germany

SPC Order

Recommended only for this consignment.

12/02/2022

Date of Submission

NMRA Ref: Number

Item

Qty

Applicant

Manufacturer/Supplier

Reason for WOR

WOR Committee Approval

24/12/2022

MD/529/01/2022

Wallace Catheters & Oocyte recovery set.

285

A. Baur & Co.(Pvt) ltd

Cooper Surgical Inc - USA

For several Hospitals in Sri Lanka (Lanka Hospital PLC/ Nawaloka Hospitals PLC & Vindana Reproductive Health Centre)

Not Recommended.

To be considered after getting NOL from the registered Local Agent.

19/01/2022

MD/553/01/2022

TC 99m Dry Tec Generator (6GBq),

DMSA,

Bridate Bromo - Billiaron, Mag3, Nanocol

26/36/

12/36/

Medical Supplies Division

Ezacibasis - Monrol Nuclear Products Co. – Turkey / Medi - Radiopharna Kit - Hungary

For Medical Supplies Division

Recommended only for this consignment. Advised to submit Pro-forma Invoice.

1/2/2022

MD/565/02/2022

Hospital Bed Manual Adjustable and Standard Accessories, Spare Parts

200

Gene Diagnostics

Jiangsu Keling Medical Appliances Co.ltd - China

PDHS - Anuradhapura

Recommended with condition.

(To be issued WOR subject to submission of free sale certificate)

09/02/2022

MD/574/02/2022

Surgical Masks

26600

Medical Supplies Division

UNICEF - Denmark

Donation to MSD

Recommended only for this consignment.

09/02/2022

MD/575/02/2022

Ventilators

Medical Supplies Division

Developing EM-a nonprofit organization

Donation to MSD

Recommended only for this consignment. To be issued WOR subject to submission of ISO, EC and Free sale certificate

09/02/2022

MD/576/02/2022

Aleve Filariasis Strip

International Organization for Migration (IOM)

Abbott Rapid Diagnostics SCA - USA

For IOM

Recommended only for this consignment.

09/01/2022

MD/577/02/2022

Immunohistochemistry Reagents

A & M Suhada Enterprises (Pvt) Ltd

Agilent Technologies Singapore (International) Pte Ltd - Singapore

for University of Colombo

Not recommended and expedite the registration.

09/02/2022

MD/578/02/2022

Pharmacy Refrigerators

Biomedica (Pvt) ltd

Haier Biomedical Co.ltd - China

UNOPS Purchase Order

Recommended only for this consignment

11/02/2022

MD/579/01/2022

Syringe Pump for Fluid Management /lading Software with standard Accessories & Spare Parts

550

Akbar Pharmaceuticals (Pvt) ltd

Smith Medical Instruments (Zhejiang) Co.ltd - China

Recommended. To be issued WOR subject to submission of NOL from Technomedics.

11/02/2022

MD/581/02/2022

Surguard Needle / 1ml Syringe / Semi Blunt Sterican Cannula

2400 / 3000 / 6000

Hemophilia Association of Sri Lanka

World Federation of Hemophilia - Canada

Donation to Hemophilia Association

Recommended only for this consignment

11/02/2022

MD/582/02/2022

Dental Wireless Curing Light Lamp

Dr. Shayanthy Nanthakumar

For Personal Use

Not recommended and advised to re-export.

11/02/2022

MD/583/02/2022

Rat Insulinoma Cell Line

Dr. M.G.A.N. Perera, Faculty of Applied Sciences, Sabaragamuwa University of Sri Lanka

Sigma Aldrich - United Kingdom

For Research Purpose.

Not Recommended. Advised to submit research protocol and Ethic committee Approval.

11/02/2022

MD/584/02/2022

Hep G2 Cell Line human

Dr. M.G.A.N. Perera, Faculty of Applied Sciences, Sabaragamuwa University of Sri Lanka

Sigma Aldrich - United Kingdom

For Research Purpose.

Not Recommended. Advised to submit research protocol and Ethic committee Approval.

11/02/2022

MD/585/02/2022

SARS COV 2 - Antigen Strip Test

10000

D & S Solutions

Labcare Diagnostics (India) Pvt ltd - India

For current pandemic situation and research purpose.

Not Recommended and advised to register the product.

03/02/2022

MD/567/02/2022

CentriMag Blood Pump System

Chatham House (Pvt) ltd

Thoratec Switzerland GmbH - Switzerland

For NHSL

Recommended only for this consignment.

07/02/2022

MD/571/02/2022

ICU Bed and Accessories

108

Kanola Hospital (Pvt) ltd

Jiangsu Saikang Medical Equipment Co.ltd - Zhangjiagang

Re- Appeal

For Newly open hospital.

Recommended only for this consignment. Get a report regarding actual bed capacity of the hospital from RDHS.

18/01/2022

MD/558/01/2022

Brera - Plasmage Device (Brand : Brera / Model : Plasmage)

Silvacos (Pvt) ltd

Brera Medical Technologies S.R.L. - Italy

Re- Appeal

Not Recommended and advised to register the product.

1/12/2021

MD/390/12/2021

Emergency Evacuation Breathing Device

SHM Ship care (Pvt) ltd

Lalizas - Greece

For Marine Industries use only.

Not Recommended and advised to register the product.

12/02/2022 - S.P.C

Date of Submission

NMRA Ref: Number

Item

Qty

Applicant

Manufacturer/

Supplier

Reason for WOR

WOR Committee Approval

12/01/2022

MD/554/01/2022

Blood Bank Reagents (Brand : ALBA Bioscience / Model : Rare Antisera)

Primecare Holdings (Pvt) ltd

ALBA Bioscience Limited - UK

SPC Tender (DHS/L/WW/35/22)

Not Recommended and informed that WOR may be considered only after submitting the Purchase Order issued by the SPC.

(Previous Minutes Changed as per the instruction given at the MDEC after the discussion of expertise.

31/01/2022

MD/559/01/2022

HLA Reagents

Emar Pharma (pvt) ltd

M/S One Lamba - USA

SPC Tender (LP/DHS/C/LB/DQ/01/85CPW/2020)

RSSOX1A-08

RSSOX1B-11

RSSOX1C-06

RSSOX2B1-8

RSSO2Q-06

RSSO2345-06

LS1PRA-14

LS2PRA - 14

LS-NC - 08

LS-AB2 - 02

ADSORB - 10

LX4CALKT-1

Page 7 of 9

LX4VERKT-1

Recommended with condition.

(To be issued only for this Items given in the invoice)

31/01/2022

MD/560/02/2022

Surgical Suture Absorbable Braided Silk Suture

Shield Medical (Pvt) ltd

M/S Futura Surgicare (Pvt) ltd - India

SPC Tender (DHS/S/WW/71/270LM/2021)

Recommended with condition. Advised to submit 1^st lot delivery schedule.

(Issue WOR for the 1^st lot on as per the delivery schedule. Informed supplier to submit file for renewal.)

27/10/2021

Immunohistochemistry Regents (Models: IR 50461-2 / M085101-2 / M361901-2)

A & M Suhada Enterprises (Pvt) ltd

Agilent Technologies - Singapore

SPC Tender

DHS/LWW/202/16WKL/2019, Date:21/07/2021

Recommended only for this consignment.

11/02/2022

MD/580/02/2022

IDL Set with Accessories

Hemas Surgicals & Diagnostics (Pvt) Ltd

Terumo BCT Ltd - USA

SPC Tender LP/DHS/SUS/WW/2/253NB/2021

Recommended only for this consignment.

12/03/2022

Date of Submission

NMRA Ref: Number

Item

Qty

Applicant

Manufacturer/Supplier

Reason for WOR

WOR Committee Approval

18/02/2022

MD/592/02/2022

Vedio Colonoscopy System with Spare Parts & Standard Accessories

Mediquipment Limited

Olympus Medical System Corporation - Japan

NHSL requested to repair. Now ready to return repaired item.

Recommended only for this consignment. (Renewal of registration is under processing.)

18/02/2022

MD/596/02/2022

Antigen Test Kit (INSTA Covid 19 Rapid Test)

10,000

Majstro Health (Pvt) ltd

M/S Seloi Health Care (Pvt) ltd - India

For Private Hospitals

Not recommended and advise to register the product.

18/02/2022

MD/611/02/2022

Test Media Device

158

Sunshine Healthcare Lanka Ltd

Novo Nordisk A/S - Denmark

Shipment Clearance

Recommended only for this consignment. Up grated model registration is under processing.

18/02/2022

MD/612/02/2022

One touch Delica Plus Lancets

One touch Delica Plus Lancing Device

25's x 2500

1's x 500

Sunshine Healthcare Lanka Ltd

LifeScan Europe GmbH - Switzerland

For Market (Out of stock situation in the market)

Recommended only for this consignment.

15/02/2022

MD/602/02/2022

· PCR Detection System.

Biomedite (pvt) ltd

Daan Gene Co. ltd of Sun Yat-Sen University - China.

Lanka Hospital Diagnostics (pvt) ltd

Recommended only for this consignment. (Only to use for Chinese people residing in Sri Lanka and out-bound travelers to china.)

· Nucleic Acid Extraction System (Smart 32 / Swift 96)

· Nucleic Acid Extraction Kit (96/32)

13984

· Detection Kit 2019-nCoV (Bioperfectus Technologies / DaAn Gene)

13952

21/02/2022

MD/610/02/2022

Patient Monitor (Central Monitor / Bedside Monitor)

Biomedical Engineering Services

Nihon Kohden - Japan

For Sri Lanka National Hospital

Recommended only for this consignment. (As this is for NHSL - Colombo)

22/12/2021

MD/468/12/2021

Oxygenerators / Disposable Oxygen Masks

Ministry of Health

Donation.

For NHSL (OPD)

Recommended only for this consignment. (As this is donation for NHSL (OPD) Colombo)

23/02/2022

MD/617/02/2022

Continuous Renal Replacement Therapy (CRRT) Machines

03 unit with 400 Accessories

Diligence Healthcare (Pvt) ltd

Infomed SA - Switzerland

For Several Government Hospital (Base Hospitals (Theldeniya, Karawanella, Nawalapitiya, Avissawella)

Recommended only for this consignment. (As this is donation by JICA for the MOH Sri Lanka)

14/02/2022

MD/619/02/2022

ESR Tube for Blood Collecting Linear ESR Analyzer

Trivitron Nawakrama Medical Technologies (Pvt) ltd

Linear Chemicals - Spain

For Teaching Hospital - Batticaloa and National Hospital - Kandy

Not recommended. Expedite the registration.

17/02/2022

MD/646/03/2022

Electric Adjustable Beds

Comfort Bedding International (Pvt) ltd

Zejiang Dreamotion Technology Co.ltd - China

For study of the product and market research

Recommended only for this consignment. Advised to submit a report to NMRA within three months.

25/02/2022

MD/650/03/2022

Clinical Chemistry Analyzer, Reagents & Accessories & Spare Parts

Analytical Instruments (pvt) ltd

Thermo Fisher Scientific - USA

For Sri Lanka Standard Institute (SLSI)

Recommended only for this consignment. (As this is for Laboratory use only)

23/02/2022

MD/626/02/2022

Programmer of Cardiac Resynchronization therapy defibrillator (Pacemaker)

Biomed International (pvt) ltd

Medtronic Europe S.a.r.l. - Switzerland

For Purpose of Programming Implantable Pacemaker

Recommended only for this consignment. (Because it is for the purpose of programming)

23/02/2022

MD/621/02/2022

Battery Pack for Defibrillator

Hemas Surgical & Diagnostics

Nihon Kohden - Japan

For Infectious Disease Hospital

Recommended only for this consignment. Subject to submission of dossier.

23/02/2022

MD/630/02/2022

Accessories for ultrasonic Aspiration System

Medapp (pvt) ltd

Soring GmbH - Germany

Not recommended. Expedite the registration.

23/02/2022

MD/632/02/2022

Reagents for Hematology Analyzer

654

Hemas Surgical & Diagnostics

Nihon Kohden - Japan

For Office of Provincial Director of Health Services Wayamba

Recommended only for this consignment. Subject to submission of dossier.

23/02/2022

MD/633/02/2022

Reagents for Hematology Analyzer

Hemas Surgical & Diagnostics

Nihon Kohden - Japan

For Office of Provincial Director of Health Services Wayamba

Recommended only for this consignment. Subject to submission of dossier.

23/02/2022

MD/634/02/2022

Spare Parts for Patient Monitors and Defibrillators

Hemas Surgical & Diagnostics

Nihon Kohden - Japan

For Sri Jayawardhanapura General Hospital

Recommended only for this consignment. Subject to submission of dossier.

23/02/2022

MD/635/02/2022

Spare Parts for Hematology Analyzer

Hemas Surgical & Diagnostics

Nihon Kohden - Japan

Sri Lanka Air Fource and Office of regional director of health services puttalam.

Recommended only for this consignment. Subject to submission of dossier.

23/02/2022

MD/636/02/2022

Spectra Optia Apheresis System

Hemas Surgical & Diagnostics

Terumo BCT Inc - USA

For Blood Bank at University Hospital - KDU

Not recommended. Expedite the registration.

23/02/2022

MD/637/02/2022

Crystalvue Non-Mydriatic Auto Funds Camera (NFC 200)

Philobiotics (Pvt) ltd

Crystalvue Medical Corporation - Taiwan

For Hospital Use (Mount Lotus Eye & ENT Hospital)

Not recommended and advised to register the product.

23/02/2022

MD/638/02/2022

OMNI gene ORAL (OM-501) / GUT (OMR-200) QIAamp DNA Micro biome Kit/Cry vials

75 / 3 / 2200

Dr. Aruna Dharshan De Silva, Biomedical Laboratory 2, Department of Paraclinical Sciences, Faculty of Medicine, General Sri John Kotelawala Defence University (KDU)

DNA Genotek Inc - Germany

For KDU

Recommended only for this consignment. (As this is for research purpose)

23/02/2022

MD/639/02/2022

Bradford Assay Kit / Goat Polyclonal to human serum albumin / Human Lipocalin 2 Elisa Kit

Avon Pharmo Chem (Pvt) ltd

Ab cam PLC - United Kingdom

For several University( For Research Purpose)

Recommended. Subject to submit Ethic Review Committee Approval.

23/02/2022

MD/640/02/2022

Surgical Instruments

J.M. Wickramarachchi & Co. (pvt) ltd

Rhein Enterprices (Pvt) ltd - Pakistan

Not recommended and advised to register the product.

23/02/2022

MD/642/02/202

College of American Pathologist (CAP) Proficiency Testing Program

108

Lanka Hospital Diagnostics (pvt) ltd

College of American Pathologist - USA

For External Quality Assuarance Programme of the Lab

Recommended only for this consignment. (CAP Accreditation)

21/02/2022

MD/653/03/2022

Nucleic Acid Isolation System / PCR Analyzer

Airport and Aviation Services (Sri Lanka) Limited

For Hambantota and Anuradhapura General Hospitals

Recommended. Subject to submit No Objection Letter from Local Agent.

07/09/2021

Oxygen Concentrator

Emerchemie NB (Ceylon) Limited

Foshan Care Medical Technology Co.ltd - China

For Covid 19 Patient

Recommended only for this consignment. (Based on the BMES Report)

17/09/2021

MD/622/09/2021

Oxygen Concentrator

Mohomed Shuraim Naushad

Shenzhen Deda Health Co.ltd - China

Not recommended and advised to re-export. Due to unsatisfactory Technical performance.

11/02/2022

MD/583/02/2022

Rat Insulinoma Cell Line

Dr. M.G.A.N. Perera, Faculty of Applied Sciences, Sabaragamuwa University of Sri Lanka

Sigma Aldrich - United Kingdom

For Research Purpose.

WOR Committee held on 12/02/2022 and committee decision was Not Recommended. Advised to submit research protocol and Ethic committee Approval.

Recommended only for this consignment.

11/02/2022

MD/584/02/2022

Hep G2 Cell Line human

Dr. M.G.A.N. Perera, Faculty of Applied Sciences, Sabaragamuwa University of Sri Lanka

Sigma Aldrich - United Kingdom

For Research Purpose.

WOR Committee held on 12/02/2022 and committee decision was Not Recommended. Advised to submit research protocol and Ethic committee Approval.

Recommended only for this consignment.

07/03/2022

MD/654/03/2022

Pulmonary Function Test Device

Tesla One (Pvt) ltd

Ganshorn Medical Electronic GmbH - Germany

Donation to IDH Hospital - Angoda

Recommended only for this consignment.

25/02/2022

MD/655/03/2022

Clinical Chemistry Analyzer, Reagents & Accessories & Spare Parts

Analytical Instruments (pvt) ltd

Thermo Fisher Scientific Oy - Finland

For Sevaral Government Institutes

Not recommended. Expedite the registration.

23/02/2022

MD/625/02/2022

Table Mounted Retractor

Gilead Innovations

Mediflex Surgical Products - USA

For Naional Hospital - Sri Lanka

Not recommended and advised to register the product.

11/03/2022

MD/658/03/2022

Lab Blender – 400ml (Brand : BagMixer – 400)

Analytical Instruments

Interscience – France.

WHO Purchas Order. (For Food Laboratory at MRI)

Recommended only for this consignment. (purchased by WHO for MRI)

11/03/2022

MD/659/03/2022

TC 99m Generator, DTPA, DMSA, MDP, MA, MIBI, Nano Scan, HIDA, ECD

26+5+1+20+3+6+2+1+6

Medical Supplies Division

Ezacibasi-Monrol Nuclear Products Co - Turkey

For NHSL.

Recommended only for this consignment.

11/03/2022

MD/660/03/2022

Evis Exera II Colonovideoscope. (CF-Q180AL0)

Mediquipment Limited

Olympus Co.ltd - Japan

Repaired Items

Recommended only for this consignment. (As this is sent earlier for repairs)

11/03/2022

MD/661/03/2022

Evis Exera II Colonovideoscope. (CF-H180AL0)

Mediquipment Limited

Olympus Co.ltd - Japan

Repaired Items

Recommended only for this consignment. (As this is sent earlier for repairs)

11/03/2022

MD/662/03/2022

Covid 19 Antigen Detecion Kits

200,000 Kits

Siba Holdings (Pvt) ltd

M/S. Meril Diagnostics Pvt ltd - India.

Not recommended and advised to register the product.

09/01/2022

MD/577/02/2022

Immunohistochemistry Reagents

A & M Suhada Enterprises (Pvt) Ltd

Agilent Technologies Singapore (International) Pte Ltd - Singapore

Appeal.

For University of Colombo.

Submitted to WOR Committee held on 12/02/2022 and committee decision was Not recommended and expedite the registration.

Not recommended. Expedite the registration. Advised to submit Ethic Review Committee Approval.

24/12/2021

MD/489/12/2021

Electric Saw

Co-op Hospital - Eravur

Wuhu Ruijin Instrument & Device Co.ltd - China

Submitted to WOR Committee held on 08/01/2022 and committee decision was Not recommended and advised to register the product.

Not recommended and advised to re-export.

5/1/2022

MD/518/01/2022

Surgical Blades

100,000

Hayleys Agro Biotech (Pvt) ltd

For Sri Lanka Export Development Board.

Submitted to WOR Committee held on 08/01/2022 and committee decision was Not Recommended. (Purchase from registered source)

Not recommended and advised to register the product.

12/03/2022 - S.P.C

Date of Submission

NMRA Ref: Number

Item

Qty

Applicant

Manufacturer/Supplier

Reason for WOR

WOR Committee Approval

14/02/2022

MD/597/02/2022

Umbilical Catheter - Sterile

7750

Medigrow International (Pvt) ltd

Silmag La Medicina Evoluciona - Argentina

LP/DHS/SUS/WW/23/017PL/2021, Date: 16/10/2020

Recommended Only for this consignment. Subject to submission of Application for registration. (Only one bidder was bid for this tender.)

14/02/2022

MD/598/02/2022

Exchange Transfusion Set Complete in tary sterile

200

Medigrow International (Pvt) ltd

Palasticab S.A.K.L - Lebanon

LP/DHS/S/WW/36/560AM/2020, Date: 18/06/2020

Recommended only for this consignment. (No registered sources.)

14/02/2022

MD/599/02/2022

Peripherally Inserted Central Catheter (PICC) 28G/1.2 Fr - 30cm

Medigrow International (Pvt) ltd

Silmag La Medicina Evoluciona - Argentina

LP/DHS/S/WW/36/560AM/2020, Date: 18/06/2020

Recommended only for this consignment. (No registered sources.)

14/02/2022

MD/600/02/2022

EDTA Blood Collecting Tube, Vacuumed, Pet Tube 2ml

2,580,000

Sethmedi International (pvt) ltd

Ningbo Foymed Medical Instruments Co.ltd - China

LP/DHS/L/WW/36/007CPW/2022, Date:30/11/2021

WOR Not recommended. Consider purchasing from a local manufacturer or register this supplier.

18/02/2022

MD/594/02/2022

Hypodermic Needles

Medisurge International

JIangsu Kangyou Medical Instrument Co.ltd - China

DHS/S/WW/26/88DC/21, Date:13/01/2021 , DHS/S/WW/26/24DC/21

WOR Not recommended and expedite the registration.

22/02/2022

MD/608/02/2022

Retinoscope with Standard Accessories Battery Powder

106

A. Baur & Co. (Pvt) ltd

WelchAllyn Inc - USA

LP/DHS/S/WW/114/552HP/21, Date: 15/11/2021

Recommended only for this consignment. Subject to submission of registration dossier.

22/02/2022

MD/609/02/2022

Exchange Transfusion Set

2250

TMI Solution (Pvt) ltd

Vygon SA - France

LP/DHS/S/WW/50/610AK/21, date: 22/12/2021

Recommended only for this consignment. Subject to submission of registration dossier.

23/02/2022

MD/616/02/2022

Rabbit Complement for HLA typing

100

Primecare Holdings (Pvt) ltd

Bag Diagnostics - German

SPC Tender DHS/L/WW/19/22 , date: 28/06/2021

Recommended only for this consignment. Subject to submission of registration dossier.

23/02/2022

MD/620/02/2022

Disposable Central Venous Catheter set (Double Lumen) / Disposable Central Venous Catheter (single Lumen)

3000

Meditechnology Holdings (pvt) ltd

Guangdong Baihe Medical Technology - China

SPC Tender DHS/S/WW/33/46KC/2021, date: 13/11/2020

Not recommended and expedite the registration.

04/03/2022

MD/649/03/2022

Balanced Salt Solution (Brand: Rins BS)

35000

Commercial Syndicate Medical (Pvt) ltd

Ain Medicare Sdn Bhd - Malaysia

DHS/PM/98/21 , date: 14/11/2020

Recommended only for this consignment. Subject to submission of registration dossier.

09/04/2022

Date of Submission

NMRA Ref: Number

Item

Qty

Applicant

Manufacturer/Supplier

Reason for WOR

WOR Committee Approval

15/03/2022

MD/673/03/2022

Tempons (Marvel Lady)

18720

Aravinds (pvt) ltd

Hangzhou Xinxiang Industrial Co.ltd - China

Recommended only for this consignment. (Not registered sources at present.)

15/03/2022

MD/674/03/2022

Repaired Item.

Spare parts and Accessories for Sterilizer.

Mediquipment Limited

Getinge Sterilization AB, Sweeden

For Lanka Hospital PLC, Office of the Regional Director of Health Services- Jaffna, Ninewells Hospital (Pvt) ltd

Recommended only for this consignment.

15/03/2022

MD/675/03/2022

Repaired Item.

Spare parts and Accessories for Sterilizer.

Hemas Surgical & Diagnostics

Nihon Kohden

For Suwa Seriya Foundation

Recommended only for this consignment.

15/03/2022

MD/676/03/2022

Pharmacy Refrigerators (Model: HYC-290, HYC-310, YDS-6YS)

Biomedica (Pvt) ltd

Haier Biomedical Co.ltd - China

For Eye Hospital Sri Lanka

Recommended only for this consignment.

24/03/2022

MD/688/03/2022

Continuous Renal Replacement Therapy Device

Diligence Healthcare (Pvt) ltd

Infomed SA - Switzerland

For Regional Directorate of Health Services - Mannar

Recommended. Issue the WOR after the local agent submits the correct clear request.

24/03/2022

MD/689/03/2022

Biosafety Cabinets (Model: HR 1200-IIA2-S)

Biomedica (Pvt) ltd

Haier Biomedical Co.ltd - China

For Sri Lanka Air Force Headquarters

Not recommended and advised to register the product. Advised to SLAF to purchase from registered sources.

30/03/2022

MD/690/04/2022

Premium plus GEEA/GIA/Endo GIA / VLOC 180 Etxation Device / Protack / Tasuture

A. Baur & Co. (Pvt) ltd

Covidie LLC - USA.

For Several Hospitals Sri Lanka. (Kings Hospital Colombo, Hemas Capital Hospital Thalawathugoda, Asiri Hospital Galle, Apeksha Hospital Maharagama, Teaching Hodpital Karapitiya, Hemas Hospital Wattala.)

Recommended only for this consignment.

04/04/2022

MD/697/04/2022

Non-Stick Bipolar Coagulation Forceps

Innomedsys International (Pvt) ltd

Adeor Medical AG - Germany

For Sri Lanka National Hospital

Not recommended and Expedite the registration.

04/04/2022

MD/699/04/2022

Resuscitator

Premium International (pvt) ltd

Medical Technology Transfer & Services Co.ltd (MTTS) - Vietnam

Donation to the Perinatal Society of Sri Lanka.

Recommended only for this consignment. Subject to initiate the product registration.

04/04/2022

MD/700/04/2022

Ahmed Glaucoma Valve

U&I Ceylon (Pvt) ltd

New World Medical Inc - USA

For National Eye Hospital, LRH and Privat Hospitals in Colombo.

Not recommended. Advised to submit details to confirm the use of the product from 2015 at LRH and other hospitals.

05/04/2022

MD/703/04/2022

HCG Urine Strip

96000

A. Baur & Co. (Pvt) ltd

HRunbio Biotech Co.ltd - China

(Out of Stock)

Not recommended and advised to register the product.

05/04/2022

MD/704/04/2022

Repaired Item.

Spare parts and Accessories for Sterilizer.

Mediquipment Limited

Geting Sterilization AB - Sweden

Repaired Item (For Lanka Hospitals PLC)

Recommended only for this consignment.

05/04/2022

MD/705/04/2022

Repaired Item.

Spare parts and Accessories for Sterilizer.

Mediquipment Limited

Olympus Co.ltd - Japan.

Repaired Item (ForHemas Hospitals (pvt) ltd)

Recommended only for this consignment.

05/04/2022

MD/706/04/2022

Q Switch Nd-Yag Laser Tattoo Removal Machine (RL-C10)

Jethawanarama Viharaya

HK Renlang Electron Technology Co.ltd - China

For monastery use only

Not recommended and advised to register the product.

05/04/2022

MD/707/04/2022

Demo Mirena Evo AG Sten Reloadable

Hemas Pharmaceuticals (pvt) ltd

Bayer Oy - Finland

For Demonstration Purpose

Recommended only for this consignment.

05/04/2022

MD/708/04/2022

Syringe Filter Units, Sterile

Atlas Populi (Pvt) ltd

Merck KGaA - Germany

For Testing Purpose.

Product Categorization.

(This item not used for medical purpose.)

05/04/2022

MD/709/04/2022

Image & Report Management System with Standard Accessories & Spare Parts (Model: Clarus 500) (Brand: Zeiss)

Dimo (Pvt) ltd

Carl Zeiss Meditec Inc - Dublin (Legal manufacturer address change and informed NMRA on 02/11/2021)

Recommended only for this consignment and Expedite the registration.

05/04/2022

MD/710/04/2022

Repaired Item.

Video Colonoscopy System with Spare Parts & Standard Accessories

Mediquipment Limited

Olympus Medical System Corporation - Japan

Repaired Item (For Lanka Hospital and Asiri Surgical Hospital)

Recommended only for this consignment.

06/04/2022

MD/711/04/2022

Xenon Light Source (Model: CLV-S40Pro)

Mediquipment Limited

Olympus Medical System Corporation - Japan

Repaired Item (For National Hospital of Sri Lanka)

Recommended only for this consignment.

06/04/2022

MD/712/04/2022

Endoscopic Ultrasound Center (Model: EU-ME1)

Mediquipment Limited

Olympus Medical System Corporation - Japan

Repaired Item (For National Hospital of Sri Lanka)

Recommended only for this consignment.

06/04/2022

MD/713/04/2022

Video System Center

Mediquipment Limited

Olympus Medical System Corporation - Japan

Repaired Item (Teaching Hospital - Jaffna)

Recommended only for this consignment.

06/04/2022

MD/714/04/2022

Urology Telescope

Mediquipment Limited

Olympus Medical System Corporation - Japan

Repaired Item (Sri Jayawardenapura General Hospital and Postgraduate Medical Training Center)

Recommended only for this consignment.

06/04/2022

MD/715/04/2022

Reagents PCR Machine

Hayleys Lifesciences (pvt) ltd

Care DX AB - Sweden

Recommended only for this consignment.

06/04/2022

MD/716/04/2022

Cryptococcus Latex Antigen Test Kits (Brand:Remel)

Hemsons International

Remel Inc - USA

For MRI

Recommended. Advised to submit NOL from Trivitron Nawakrama Medical Technologies (Pvt) ltd then issue WOR.

05/04/2022

MD/719/04/2022

Artificial Limbs

Dr. B. Panagamuwa, Meththa Rehabilitation Foundation

The Meththa Foundation - UK

Donation

Recommended only for this consignment.

07/04/2022

MD/722/04/2022

TC 99m Generator (12.5GBq), MDP, Nanocole

26+260+12

Medical Supplies Division

Ezacibasi-Monrol Nuclear Products Co- Turkey / Medi-Radiopharma Kft - Hungary

Donation

(For NMU, Apeksha Hospital)

Recommended only for this consignment.

06/04/2022

MD/723/04/2022

Air Cylinder

SHM Shipcare (pvt) ltd

Lifesaving Purpose.

Not recommended and advised to register the product.

15/03/2022

MD/720/04/2022

Medium 199-Hanks Balanced Salt (500ml Bottles)

Analytical Instruments

Thermo Fisher - USA

For Lady Ridgway Hospital

Recommended only for this consignment.

24/12/2022

MD/529/01/2022

Wallace Catheters & Oocyte recovery set.

285

A. Baur & Co.(Pvt) ltd

Cooper Surgical Inc - USA

For several Hospitals in Sri Lanka (Lanka Hospital PLC/ Nawaloka Hospitals PLC & Vindana Reproductive Health Centre)

Recommended only for this consignment.

23/02/2022

MD/625/02/2022

Table Mounted Retractor

Gilead Innovations

Mediflex Surgical Products - USA

For National Hospital - Sri Lanka

Not recommended and advised to register the product.

08/04/2022

MD/725/04/2022

808nm Laser Hair Removal Machine

Durdans Hospital

Sus Advancing Technology Co.ltd - China

For Hospital Use.

Not recommended and advised to register the product.

08/04/2022

MD/726/04/2022

TaqMan RNase P Instrument (ViiA 7 System) / 384 well Verification Plate, Pack of 1 kit and TaqMan RNase P Instrument (ViiA 7 System) 96 well Verification Plate, Pack of 1 Kit

National Programme for Tuberculosis Control & Chest Diseases

Fisher Healthcare UK Ltd - UK

Donation to NPTCCD

Recommended only for this consignment.

05/04/2022

MD/724/04/2022

ELISA Kit

University of Ruhuna

Wuhan Huamei Biotech Co.ltd - China

Donation

Recommended. Advised to submit WOR Application, Invoice, Manufacturer details, Product Information.

08/04/2022

MD/727/04/2022

Oxylog 3000 Ventilator

District General Hospital - Matara

Donation

Recommended only for this consignment. Advised to submit WOR Application, Invoice, Manufacturer details, Product Information.

09/04/2022 - S.P.C

Date of Submission

NMRA Ref: Number

Item

Qty

Applicant

Manufacturer/Supplier

Reason for WOR

WOR Committee Approval

22/03/2022

MD/677/03/2022

E.C.G. Recording Paper

312,000 Rolls

Emar Pharma (Pvt) ltd

M/S Chhenna Corporation – India.

LP/DHS/L/WW/97/109WAC/21, date: 12/10/2021

Recommended only for this consignment.

24/03/2022

MD/694/04/2022

Capsular Tension Ring with fixtion arm, left, size 10mm - 12mm sterile / Iris Respositor, Titanium and others

Safe Globes Lanka (pvt) ltd

Plus Surgicals – Lolkata.

LP/DHS/S/WW/101/652HP/21, date: 20/01/2022 , LP/DHS/S/WW/114/670HP/21, date: 11/02/2022

Recommended only for this consignment.

22/03/2022

MD/678/03/2022

Blood Bank Reagents

Primecare Holdings (Pvt) ltd

ALBA Bioscience Limited - UK.

DHS/L/WW/33/22

(Not attached SPC Indent)

Not recommended and advised to register the product.

27/10/2021

MD/318/11/2021

Ortho Phythalaldehyde Solution 0.55% w/v

N/A

L W Medicals

M/s. Unilab Chemicals and Pharmaceuticals (pvt) ltd - India

DHS/RP/407/2020

Not recommended and advised to register the product.

Agenda for Waiver of Registration Committee - Device 07/05/2022

Date of Submission

NMRA Ref: Number

Item

Qty

Applicant

Manufacturer/Supplier

Reason for WOR

WOR Committee Approval

21/04/2022

MD/732/04/2022

Rehabilitatior Equipment

MJF Charitable Foundation

Wheelstoheal - UK

Donation to Lady Ridgway Hospital

Recommended with condition.

Subject to submission of distribution list and requested letters from receivers on items and quantity.

21/04/2022

MD/734/04/2022

Viral Transport Medium Kit

1000

Siba Holdings

M/s Meril Diagnostics (Pvt) ltd - India

For Sri Lanka Market

Not recommended and Expedite the registration.

21/04/2022

MD/735/04/2022

Tencell Cuvettes for Clinical Chemistry Analyzer, Reagents & Accessories & Spare Parts (Indiko)

150+50

Analytical Instruments

Thermo Fisher Scientific Oy - Finland

For Sirimavo Bandaranayeke Specialized Children's Hospital - Peradeniya and RDHS - Jaffna.

Not recommended and Expedite the registration.

25/04/2022

MD/748/04/2022

Oxygen Generator Plant

Delmege Forsyth& Co.ltd

Meditech TechnologyCorp.ltd-China

Ministry of Health Tender

Currently NMRA not regulating Oxygen Generator Plant. If tender is awarded after BMES evaluation to issue NOL.

25/04/2022

MD/749/04/2022

Microtome Blade

21 CV

Analytical Instruments

Epredia Netherland B.V - Netherlands

For National Hospital in Sri Lanka

Not recommended and advised to register the product.

27/04/2022

MD/651/04/2022

Mobile X-Ray System Mobirex i9 / CT Scanner TSX-305A

1 + 1

Mediquipment Limited

Canon Medical Systems Corporation - Japan

For Suwasevana Hospitals (Pvt) ltd

Not recommended and advised to register the product.

04/05/2022

MD/757/05/2022

Male Condoms (53mm), Femail Condoms (143mm) , Lubricants

5350+10+700

National STD/AIDS Control Programme

Cupid Ltd - India

Donation

Recommended only for this consignment.

08/04/2022

MD/725/04/2022

808nm Laser Hair Removal Machine

Durdans Hospital

Sus Advancing Technology Co.ltd - China

For Hospital Use.

Not recommended and advised to register the product. (No single user of the product. For hospital multiple user)

09/01/2022

MD/577/02/2022

Immunohistochemistry Reagents

A & M Suhada Enterprises (Pvt) Ltd

Agilent Technologies Singapore (International) Pte Ltd - Singapore

For University of Colombo.

Not recommended. Need to submit the clinical clearance letter for research purpose.

07/05/2022 - S.P.C

Date of Submission

NMRA Ref: Number

Item

Qty

Applicant

Manufacturer/Supplier

Reason for WOR

WOR Committee Approval

04/05/2022

MD/756/05/2022

Stainless Steel Needle Suture (Brand: Stelus)

10,100

Premier Healthcare (Pvt) ltd

Lotus Surgical (Pvt) ltd - India

SPC Tender

DHS/S/WW/104/100RA/21, dated: 12/01/2021

Recommended with condition. Subject to submission of new dossier.

11/06/2022

Date of Submission

NMRA Ref: Number

Item

Qty

Invoice / Tender Number

Applicant

Manufacturer/ Supplier

Reason for WOR

WOR Committee Approval

20/05/2022

MD/770/05/2022

Pharmacy Refrigerators

HRP-003-Biomedica-2022

Biomedica (Pvt) ltd

Haier Biomedical Co.ltd - China

For RDHS - Anuradhapura

Recommended only for this consignment and advised to submit dossier for registration.

09/05/2022

MD/784/05/2022

Hyperbaric Oxygen Therapy

RE2022-026P, date: 27/04/2022

Analytical Instruments

Haux-Life-Support GmbH - Germany

For Ministry of Defence

Not recommended and advised to register the product. Apply for registration to expedite.

20/05/2022

MD/785/05/2022

Surgical Items.

1. Neoprene Hinge Knee Support NP-05.

2. Thumb Support WS - 06

S/C/004/2022, Date: 19/05/2022

Dr. L.K.D. Chandana R. Karunathilaka, Musculoskeletal Sciences Department, University Hospital- KDU

Local Agent: Avenier Pharma (Pvt) ltd)

Manufacturer - Aadhar Medicare Pvt ltd - India

Supplier - Plus Medical Devices India (P) ltd - India

For KDU

Not recommended and expedite the registration.

(Email - P7)

24/05/2022

MD/787/05/2022

Sodium Bicarbonate Powder for Hemodial ysis (Bibag 5008)

15000 Pce

4503066044, date: 19/05/2022

Fresenius Medical Care

Fresenius Medical Care - Germany

For haemodialysis treatments procedure of patients with chronic kindly disease.

Recommended only for this consignment. Subject to submission of dossier.

03/06/2022

MD/798/06/2022

Gel Filled Textured Mammery Implant

110 Packs

0003-009012, date: 22/03/2022

CIC Holdings PLC

Biosil Limited - UK

Recommended only for this consignment. Advised to submit for registration.

27/05/2022

MD/799/06/2022

1 Unit of Aqua B Plus 1000 with standard Accessories

INV/SP/356/05/22, date: 27/05/2022

Fresenius Medical Care

Vivonic GmbH - Germany for Fresenius Medical Care AG & Co KGaA - Germany.

Re-Export

Pending Decision. Advised to submit a letter from the parent company for authorization to re-export.

06/06/2022

MD/811/06/2021

College of American Pathologist (CAP) Proficiency Testing Program

As per the invoice

384838 (CAP:902147901)

Lanka Hospital Diagnostics (Pvt) ltd

College of American Pathologist - USA

For CAP Programme

Recommended only for this consignment.

06/06/0202

MD/812/06/2022

Next Generation Sequencing Reagents

As per the invoice

73912698SO, date: 18/05/2022

Genelabs Medical (pvt) ltd

Life technologies Holdings Pte Ltd - Singapore.

For KDU

Recommended. Issue WOR after obtaining NOL from Analytical Instrument.

06/06/0202

MD/814/06/2022

Reagents for Hematology Analyzer

10025701, date: 15/04/2022

Hemas Surgical & Diagnostics

Nihon Kohden - Japan

For Sri Lanka Air Force Headquarters

Recommended only for this consignment. Advised to submit file for registration.

06/06/0202

MD/816/06/2022

Cold disinfection for Haemodialysis Machines

777634582, date: 22/12/2021

Fresenius Medical Care

Fresenius Medical Care AG & Co. - Germany

For haemodialysis treatments procedure of patients with chronic kindly disease.

Not recommended. Expedite registration process after submission of sample.

08/04/2022

MD/725/04/2022

808nm Laser Hair Removal Machine

PI22031663, date: 16/03/2022

Durdans Hospital

Sus Advancing Technology Co.ltd - China

For Hospital Use.

Not recommended and advised to register the product or purchase registered product.

11/06/2022 - S.P.C

Date of Submission

NMRA Ref: Number

Item

Qty

Invoice / Tender Number

Applicant

Manufacturer/ Supplier

Reason for WOR

WOR Committee Approval

23/05/2022

MD/786/05/2022

Spinal Pillow (Gillespie Type)

DHS/SUS/WW/122/22, date:08/09/2021

Medapp (Pvt) ltd

Ms. Zhangjiagang Huaxin Medical - China

SPC Order

Not recommended and advised to register the product.

27/05/2022

MD/800/06/2022

Mini Caps

180,000

DHS/RSS/RQ/24/22 date: 22/04/2022

Kish International (Pvt) ltd

ST. Stone Medical Devices (Pvt) ltd - India

SPC Tender

Not recommended. Refer to college of nephrology to expedite the registration.

(Email - P9)

27/05/2022

MD/802/06/2022

Riboflavin Solution for Control Cross-Linking (CXL)

400

DHS/P/WW/324/22, date: 09/11/2021

Lenstech Innovations (Pvt) ltd

Ophthalmica (Pty) Ltd - South Korea

SPC Tender (No SPC Tender Document, ISO, EC, and Free Sale Certificates)

Not coming Under NMRA.

Issue Product Categorization.

27/05/2022

MD/803/06/2022

Rongeurs (Surgical Instruments) (Brand: Aesculap)

231271773, date: 18/01/2021

B Braun Lanka (pvt) ltd

Aesculap AG, Am Aesculap - Germany

SPC Tender (No SPC Tender Document, ISO, EC, and Free Sale Certificates)

Recommended only for this consignment.

27/05/2022

MD/804/06/2022

Dental Excavator

643

DHS/S/WW/106/1092MT/20, date: 11/11/2021

B Braun Lanka (pvt) ltd

Aesculap AG, Am Aesculap - Germany

SPC Tender (No ISO, EC, and Free Sale Certificates)

Not recommended. Expedite the registration.

(Email - P33)

27/05/2022

MD/805/06/2022

Rongeurs (Surgical Instruments) (Brand: Aesculap)

231446977, date: 05/01/2022

B Braun Lanka (pvt) ltd

Aesculap AG, Am Aesculap - Germany

SPC Tender (No SPC Tender Document, ISO, EC, and Free Sale Certificates)

Recommended only for this consignment.

27/05/2022

MD/806/06/2022

Rongeurs (Surgical Instruments) (Brand: Aesculap)

231138897, date: 13/03/2020

B Braun Lanka (pvt) ltd

Aesculap AG, Am Aesculap - Germany

SPC Tender (No SPC Tender Document, ISO, EC, and Free Sale Certificates)

Recommended only for this consignment.

27/05/2022

MD/807/06/2022

Sponge and Dressing Forceps (Brand: Aesculap)

DHS/SUS/WW/26/195KM/21, date: 28/04/2021

B Braun Lanka (pvt) ltd

Aesculap AG, Am Aesculap - Germany

SPC Tender (No ISO, EC, and Free Sale Certificates)

Not recommended. Expedite the registration.

27/05/2022

MD/808/06/2022

Dental Instruments (Dental Excavater)

231013411, date: 29/07/2019

B Braun Lanka (pvt) ltd

Aesculap AG, Am Aesculap - Germany

SPC Tender (No SPC Tender Document, ISO, EC, and Free Sale Certificates)

Not recommended. Expedite the registration.

(Email - P33)

06/06/2022

MD/815/06/2022

Dental Probes

938

DHS/RS/RQ/108/20 date; 24/02/2021

Rivomed Holdings (pvt) ltd

Snaa Industries - pakistan

SPC Tender

Not recommended and advised to register the product.

Advised to NOL from Indro (Pvt) ltd.

01/06/2022

MD/801/06/2022

Trutone Emote Electrictrolarynx Kit

DHS/S/WW/81/528JT/20, date: 05/11/2022

Dilmark Medicare (Pvt) ltd

Atos Medical - Sweden

Appeal -

SPC Tender

Not recommended. Expedite the registration.

(P9 - email)

04/03/2022

MD/649/03/2022

Balanced Salt Solution (Brand: Rins BS)

35000

DHS/PM/98/21, date: 14/11/2020

Commercial Syndicate Medical (Pvt) ltd

Ain Medicare Sdn Bhd - Malaysia

SPC Tender

DHS/PM/98/21, date: 14/11/2020

Recommended only for this consignment. Subject to submit for registration within 90 days.

List of issued WORs for IR Thermometers

Ser. No.	Item	Invoice No.	Quantity	Applicant	Supplier	Status
1	Infrared Thermometer	8158135101	50	Mr. Asanka Gajaweera	Yin Yu Tian Technology Co., Ltd, China.	ISSUED
2	Infrared Thermometer	7420951532	1	DHL Global Forwarding Lanka PVT.LTD	Yin Yu Tian Technology Co., Ltd, China.	ISSUED
3	Infrared Thermometer	PTS-20-0420-01R	20	Samson Rubber products Pvt. Ltd	AViTA Corporation., Taiwan.	ISSUED
4	Infrared Thermometer	3081827792	5	Nature’s Beauty Creations Ltd	A & D Company Ltd., Japan.	ISSUED
5	Infrared Thermometer	HS20200323E	500	Premium International (Pvt) Ltd	Contec Medical Systems Co. Ltd, China.	ISSUED
6	Infrared Thermometer	MM20032005	100	TMI Solutions (Pvt) Limited	Putian King Baby care Electronic Co., Ltd., China.	ISSUED
7	Infrared Thermometers	20KTHW007 Dated 24th April 2020 USD 1728.00	96	Wasana Udyoga Bombuwalage	Zhegiang Mondial Electronic Technology Co., Ltd. China	ISSUED


8	Infrared Thermometers	20200429CM8 Dated 20th April 2020 USD 2000.00	500	Cayenne International (Pvt.) Limited	Shenzhen LeZhongxing Technology Co., Ltd., China	ISSUED 11.05.2020


9	Infrared Thermometers	TW20200511-003	750	A Plus Connects Pvt. Ltd	Chonngqing Guiguzi Medical Device Technology Co., Ltd. China.	29.05.20
		dated 11^th May 2020
		USD 21,000.00
10	Infrared Thermometers	HIL20200403001	1000	Abans Plc	ShenZhen Sense Time Technology Co., Ltd., Hong Kong	27.05.20
		dated 03th April 2020
		USD 36500.00
11	Automated Thermal Imaging System	TT_0004	3	Abans Plc	ShenZhen Sense Time Technology Co., Ltd., Hong Kong	27.05.20
		dated 20^th March 2020
		USD 34500.00

12	Infrared Thermometers	ENV2005	3	Abans Plc	Hunan Honggao Electronic Technology Co., Ltd., China	30.05.20
		dated 26^th May 2020
		USD 81.00
13	Infrared Thermometer	BBLY-106	4680	Akbar Pharmaceutical Pvt., Ltd.	Yiwu Babyly Medical Device Co., Ltd., China	27.05.20
		dated 04^th May 2020
		USD 163800.00
14	Infrared Thermometer	20200505	250	AYU Ventures Pvt. Ltd	Hebei Evidence –Based Medical Technology Co. Ltd., China
		dated 5^th May 2020
		USD 6923.00
15	Infrared Thermometer	EWQSI200200328BH dated 26^th April 20	500	Biovest Healthcare Pvt., Ltd	Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. China	27.05.20
		USD 16700.00
16	Infrared Thermometer	20KTHW007	96	Wasana Udyoga Bombuwalage	Zhegiang Mondial Electronic Technology Co., Ltd. China	10.05.20
		dated 24th April 2020
		USD 1728.00
17	Infrared Thermometer	CCC-LK-001, CCC-LK-003, CCC-LK-004, CCC-LK-005, dated 23^rd March 20	8	China National Cable Engineering Corporation	CHTC Jiahua Nonwoven Co., Ltd. China	19.05.20

18	Infrared Thermometer	20-04565	500	Certis Lanka Technology & Consultancy (Pvt) Limited	Harbin Xiande Technology Development Co. Ltd, China	14.05.20
		dated 28th April 2020
		15345
19	Infrared Thermometer	CETC/ACCESS/20200429 dated 29th April 2020	600	Access international (Pvt) Ltd	CETC International Co., Ltd., China	26.05.20
		USD 33000.00
20	Infrared Thermometer	FOC28850/2020	800	Chamathkar Holdings Pvt Ltd	Zhang ZhouXin Tian Jiang Medical Equipment Co., Ltd.	21.05.20
		dated 25th March 2020			China
		USD 4450.00
21	Infrared Thermometer	40420136	150	CMN Distributors Lanka Pvt. Ltd	Yobekan Medical Equipment Co., Ltd. China	26.05.20
		dated 30th April 2020
		USD 4800.00
22	Infrared Thermometer	NAK0420UPS1094	885	D K Holdings	Guizhou Teakang Electronics Co., Ltd. China	13.05.20
		dated 29th April 2020
		USD 4485.00
23	Infrared Thermometer	ANX20200 427/ 03RA dated 27th April 2020	100	Deem Manufactures	Putian Joko Electronic Co. Ltd, China	22.05.20
		USD 2500.00
24	Infrared Thermometer	BF20200428IL0033 dated 28th April 2020	240	EWIS Colombo Limited	Shenzhen Jufukang Electronic Co., Ltd., China	26.05.20
		USD 5811.00
25	Infrared Thermometer	28th April 2020	550	Electronic IQ (Pvt) Limited	Jiang Xi Jeavox Co., Ltd. China	21.05.20
		USD 16225.00
26	Infrared Thermometer	CIURLPI200427 29.04.2020	25200	Digital Cells (Pvt) Ltd	Hunan Honggao Electronic Technology Co. Ltd, China	12.05.20
		CIURLPI200428 29.04.2020
		CIURLPI2004291 30.04.2020
		CIURLPI2004292 30.04.2020
		CIURLPI200504 05.05.2020
		USD 225700.00
27	Infrared Thermometer	ENH/PI/2020/2003 dated 04th May 2020	680	Envision Holdings International Pvt Ltd	Longnan Ren Zhong Medical Equipment Co., Ltd. China	10.05.20
		USD 8160.00
28	Infrared Thermometer	K2020/067	1000	Evercare Trading Company	Shenzhen Zhengkang Technology Co. Ltd, China	13.05.20
		dated 27th April 2020
		USD 5650.00
29	Infrared Thermometer	USD 24000.00	2000	Fine Care Pharmaceuticals (Pvt) Ltd	Hangzhou Universal Electronic Company, China	30.05.20
		CFL-NW -2020-5- 17-001 dated 17th May 2020
30	Infrared Thermometer	2020FSR103	500	Fine Surgicals	Wenzhou Yosun Medical Technology Co Ltd, China	28.05.20
		dated 13th May 2020
		USD 10930.00
31	Infrared Thermometer	FCHS20200507	900	Future Need	Huizhou Xiaoou Technology Co., Ltd., China	12.05.20
		dated 05th March 2020
		USD 9613.00
32	Infrared Thermometer	FCHS20200508	1000	Future Need	Huizhou Xiaoou Technology Co., Ltd., China	12.05.20
		dated 16th March 2020
		10253
33	Infrared Thermometer	KAY20200429	1000	Gene Diagnostics	Hunan Honggao Electronic Technology Co., Ltd. China	26.05.20
		dated 13th May 2020
		USD 27967.00
34	Infrared Thermometer	EWQLK20200504GS dated 04th May 2020	1750	George Steuart Health (Pvt) Ltd	Lepu Medical Technology, (Beijing) Co., Ltd. China	14.05.20
		USD 49875.00
35	Infrared Thermometer	SJW-K20200420001 dated 20th April 2020	215	Globe express International Pvt. Ltd	ShenZhen Changkun Technology Co. Ltd. China	26.05.20
		USD 2580.00
36	Infrared Thermometer	10313052020	240	Helicon Pvt Ltd.	GuangDong Jaki Technology & Eduction Co Ltd, China.	28.05.20
		dated 09th May 2020
		USD 5050.00
37	Infrared Thermometer	CS20200514I	1000	Advanced Digital Technology	Hunan JRT Medical Devices Co., Ltd. China	30.05.20
		dated 14th May 2020
		USD 14500.00
38	Infrared Thermometer	ND202050803	800	Himale Trading	Hunan Phicon Biotech Co Ltd. China	22.05.20
		dated 15th May 2020
		USD 7310.00
39	Infrared Thermometer	ENH/PI/2020/2004 dated 04th May 2020	120	HMT international	Longnan Ren Zhong Medical Equipment Co., Ltd. China	10.05.20
		USD 1800.00
40	Infrared Thermometer	MR200518-HMT01 dated 18-May-2020	280	H M T International Ltd	Longnan RenZhong Medical Equipment Co., Ltd. China	23.05.20
		USD 3360.00
41	Infrared Thermometer	2020-27/04/DRKK01a dated 8th May 2020	1000	Innogen Lanka (Pvt) Ltd	Shenzhen EP Intelligent Technology Co. Ltd., China	29.05.20
		USD 32000.00
42	Infrared Thermometer	2020-12/05/DRKK01a dated 13th May 2020	1000	Innogen Lanka (Pvt) Ltd	Shenzhen EP Intelligent Technology Co. Ltd., China	29.05.20
		USD 32000.00
43	Infrared Thermometer	GS20200508	576	Mr. KACS Rodrigo	Ganzhou Manchang Medical Equipment Co.,Ltd. China	29.05.20
		dated 8th May 2020
		USD 25483.00
44	Infrared Thermometer	2020032401	1	JVSN Trading & Engineering Co Pvt. Ltd	Winner Medical Co. Ltd., China	10.05.20
		dated 24th March 2020
		USD 29.00
45	Infrared Thermometer	DY20200508019 dated 8th May 2020	100	Keygen Security Pvt Ltd	Dytech Technology Ltd., Hong Kong	28.05.20
		USD 2600.00
46	Infrared Thermometer	VM20200502	25	Laboratory Equipment Co Pvt Ltd	Jiangxi Aicare Medical Technology Co Ltd, China	30.05.20
		dated 2nd May 2020
		USD 875.00
47	Infrared Thermometer	HWZ20D127-001A	250	MAT International Trading Co. Pvt. Ltd	Xiamen Jizhi Technology Co. Ltd., China	16.05.20
		dated 30th April 2020
		USD 6750.00
48	Infrared Thermometer	HWZ20D127-002	500	MAT International Trading Co. Pvt. Ltd	Xiamen Jizhi Technology Co. Ltd., China	30.05.20
		dated 11th May 2020
		USD 13500.00
49	Infrared Thermometer	SYI090520X	2000	Max Lanka Trading Co. Pvt. Ltd	Yichun Kang Guan Zhi Xin Medical Technology Co. Ltd., China	16.05.20
		dated 07th May 2020
		USD 34000.00
50	Infrared Thermometer	GT2020505012	280	Maxwell Healthcare (Pvt) Ltd	Guangdong Genial Technology Co. Ltd, China	23.05.20
		dated 7-May-2020
		USD 7000.00
51	Infrared Thermometer	LT20200427SYPLK	500	Med Solutions Pvt., Ltd.	ShenZhen Zhengkang Technology Co., Ltd. China	30.05.20
		dated 27th April 2020
		USD 12800.00
52	Infrared Thermometer	DK200503	1000	Medex Holding (Pvt) Limited	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. China	21.05.20
		dated 12th May 2020
		USD 21000.00
53	Infrared Thermometer	VM20200428	2000	Meditechnology Holdings (Pvt) Ltd	Jiangxi AICARE Medical Technology Co. Ltd, China	12.05.20
		dated 28th April 2020
		USD 90000.00
54	Infrared Thermometer	PI#20200505-Mega-P1- dated 13th May 2020	1000	Mega Meditech Pvt Ltd	TaiDoc Technology Corporation, Taiwan	30.05.20
		USD 12000.00
55	Infrared Thermometer	AK-ECPL-1038/MORICH dated 28th April 2020	120	Morich Trading (Pvt.) Ltd	Guangzhou Berrcom Medical Device Co., Ltd. China	10.05.20
		USD 1800.00
56	Non- contact Infrared Thermometer (Model: BZ- R6)	Commercial invoice No: SI- 178	1000	San Trading Enterprises (Pvt) Ltd,	Henan Bingzun Industrial Co. Ltd, China for ENG Exports Ltd, Hong Kong for	Issued
57	Medical Infrared Forehead Thermometer (Model RT- 105)	300 pcs Proforma Invoice No: G202004 -01L	11350 USD	Trade first (Pvt) Ltd,	Dongguan Rongfeng Medical Co Ltd, China for Jinan Grace Industry Co. Ltd, China	Issued
58	Infra red Thermometers	INVOCIE NO.:BIOBASE20200416SR of 16^th April 2020	50	Enviroequip pvt ltd no 87, old Kottawa road mirihana nugegoda	from Biobase Biodustry (Shandong) Co., Ltd., Shandong Biobase Industry Park, crossed between Mingbu Road and East Jingshi Road, Mingshui Economic Development Zone, Shandong Province, China.	Issued

59	Infrared Thermometers	commercial invoice NO. LY19-0318C08 of 23 ^rd March 2020	200	Enviroequip pvt ltd no 87, old Kottawa road mirihana nugegoda	LIYI Environmental Technology Co.,Ltd, 02-03, 6/F, Gaosheng Technology Park,Nancheng District , Dongguan , Guangdong, China (LIYI GROUP (HONGKONG) CO.,LTD,) .	ISSUED

60	IR Thermometers	Invoice No HIL20200619001 of dated 19^th May 2020	3045	Abans PLC, 498, Galle road, Colombo 03, Sri Lanka	Heier International (HK) Limited, Room 1908, Habour center25, Harbour road, Wanchai, Hong Kong, The product is manufactured by Shenzhen Jumper Medical Equipment Co. Ltd, D Building, No 71, Xiantian road, Fuyong street, Baoan, Shenzhen, Guangdong, China.	issued
61	IR Thermometer	Invoices: EWQLK20200325GS		George Steuart Health	Lepu Medical Technology (Beijing)Co.Ltd	ISSUED
62	Thermometer	LK/0551	5	LTL Transformers (Pvt) Ltd	Ningbo Winner Technology Co. Ltd	ISSUED
63	IR Thermometer		1,000	Worldwide Trading Lanka(pvt) Ltd	Rubine ChinaInternal (Private) Limited,
64	IR Thermometer		100	Lanerolle BSA	M/s. Evangel
					International Machinery Limited,
65	IR Thermometer		1,000	E-W Information System Ltd	Hongkong ChoiceElectronics Co. Limited,
66	Infared Thermometers & Face Mask	4932129		Emerchemie NB ( Ceylon) Ltd	Tesma Insaat Dis Ticaret Sanyayi Limited Sirketi	Issued

67	IR Thermometer	EWQLK20200417GS EWQLK20200423GS	1400 1750	George Steuart Health (Pvt) Ltd No. 7E,Post Masters Place, Off Templers Road, Mount Lavinia,	Lepu Medical Technology (Beijing) Co, Ltd. Building 3, No. 37 Chao Qian Road，Changping Tech. Zone，Beijing, China 100176.	Issued




68	Infrared Thermometers			United Nations World Food Programme	Jiangxi Aicare Medical Technology Co. Ltd - China	Recommended only for this consignment
69	Infrared Thermal Imaging Device.			Excel Trading International (Pvt) Ltd.	Shenzhan Kuang -Chi Space Technology Co.Ltd	Issue WOR only for this consignment and advised to register the product in future importation
70	Infrared Thermometers & Disposable Face Mask			Heineken Lanka Ltd	Heineken Asia Pacific Pte. Ltd - Singapore	Recommended only for these consignment
71	Infrared Forehead Thermometer			CIC Vetcare (Pvt) Ltd	Shanghai Joylab Medical Instruments Co. Ltd - China	Recommended only for these consignment
72	Infrared Thermometers			Dimuthu Tex	Hunan Tuogao Medical Technology Co.Ltd - China	Recommended only for these consignment

73	Infrared Forehead Thermometer	SS20200519 (USD 3200)	200	S & S Trading	HongKong Greaty Industry Co., Limited, China	issued

74	Infrared Thermometers	Invoice No. ZZDF-20200509-03 dated 9th May 2020 USD 24776.00	1008	TECHNIP Engineering Company	Zhejiang Mondial Electronic Technology Ltd. China	26.06.20

75	Infrared Thermometer	Invoice No. 439043060 dated 20th April 2020	50	ABC Trade & Investment Pvt Ltd	Shenzhen Xinhonggjing Photoelectric Technology Co. Ltd. China	30.06.20
		USD 1970.00
76	Infrared Thermometers	Invoice No. K2020/079 dated 11th May 2020	1000	Evercare Trading Company	Shenzhen Zhengkang Technology Co. Ltd, China	07.06.20
		USD 5650.00
77	Infrared Thermometer	Invoice No. STL 20019 dated 14th May 2020	650	Evercare Trading Company	Guangzhou PHICON Biotech Co., Ltd., China	10.06.20
		USD 2650.00
78	Infrared Thermometer	invoice No. 200428-SK dated 28th April 2020	520	HealthTrust Pharmaceuticals (Pvt) Ltd	Xiamen Ants Bro Technology Co., Ltd., China	26.06.20
		USD 12480.00
79	Infrared Thermometers	Invoice No. 517919 dated 13th May 2020	155	A.Baur & Company Ltd	Exergen Corporation, USA	03.07.20
		USD 14766.00
80	Infrared Thermometers	Invoice No. SO-20000541 dated 09th June 2020	500	A.Baur & Company Ltd.	Kunshan Radiant Innovation Co Ltd. Japan	15.07.20
		USD 11500.00
81	Infrared Thermometers	Invoice No. XTD 002 dated 18th May 2020.	180	EVERGREEN Lighting and Electrical Lanka (Pvt) Ltd	Harbin Xiande Technology Development Co. Ltd, China	15.07.20
		USD 1928.00
82	Infrared Thermometers	Invoice No. 9409611	100	Morison PLC	Jiangxi AICARE Medical Technology Co. Ltd. China	01.08.20
		USD 2200.00
83	Infrared Thermometers	Invoice No. SU705-01/2020 dated 10th May 2020	1	3DH International Pvt Ltd	Huizhou Xiao’ ou Technology Co Ltd. China	02.06.20
		USD 26.00
84	Infrared Thermometer	Invoice No. AJ2O2Oo412M dated 12th April 2020.	576	Access Engineering PLC	Bella (GZ) Inteligent Information Technology Co. Ltd	12.06.20
		USD 14465.00
85	Infrared Thermometer	invoice No. 8881832387 dated 08th May 2020	40	Advanced Digital Technology	Shangye Nuoan Medical Equipment Co Ltd. China	26.06.20
		USD 720.00
86	Infrared Thermometer	Invoice No. 7310-2005-ATA-0000 dated 26th May 2020. USD 15.00	1	ATA International Pvt Ltd	Joytech Healthcare Co Ltd, China	10.06.20
87	Infrared Thermometer	Invoice No. 20-0519 dated 29th May 2020 GBP 100.00	2	ATA International Pvt Ltd	Norwood Instruments Ltd, England.	10.06.20
88	Infrared Thermometer	Invoice No. TW20200511-002 dated 11th May 2020.	300	Axero Associates Pvt Ltd	Chongqing Guiguzi Medical Device Technology Co., Ltd. China	02.06.20
		11100

89	Infrared Thermometers only	Invoice No. HRP-007-Biomedica-2020 dated 04th May 2020 . USD 3000.00	100	Biomedica (Pvt) Ltd	Quingdao Haier Biomedical Co Ltd, China	19.06.20
90	Infrared Thermometer	Invoice No. BPP20200428M2 dated 28th April 2020.	123	Burse Pharmaceuticals Pvt Ltd	Hunan Honggao	09.06.20
		USD 2583.00			Electronic Technology Co., Ltd, China

91	Infrared Thermometer	Invoice No. CHEC/BG/00054 dated 13th May 2020 USD 4200.00	140	China Harbour Engineering Company Lanka Ltd	Shenzhen Quick Zoom Technology Co., Ltd. China	11.06.20
92	Infrared Thermometer	Invoice No. KTD2020051021EV dated 19th May 2020. USD 10000.00	505	Chemsoul Health Care (Pvt) Ltd	Henan Bingzun Industrial Co., Ltd. China.	02.06.20
93	Infrared Thermometer	Invoice No. 20200519 dated 19th May 2020	100	Exclusive designer fabrics Pvt Ltd	Hangzhou Hua’an Medical & Health Instruments Co., Ltd. China	02.06.20
		USD 2700.00
94	Infrared Thermometer	Invoice No. PI-SCW08052 dated 29th May 2020	20000	Dowell Medico Pvt Ltd	Harbin Xiande Technology Development Co. Ltd. China	09.06.20
		USD 600000.00
95	Infrared Thermometer	Invoice No. LH20200426 dated 26th April 2020	80	Eco Fresh World International Pvt Ltd	Huizhou Xiaoou Technology Co Ltd. China	11.06.20
		USD 2560.00
96	Infrared Thermometers	Invoice No. BST20200422 dated 22ndApril 2020		Future Need	Shenzhen Besiter Power Bank Technology Co., Ltd, China	18.06.20
97	Infrared Thermometer	Invoice No. 3/13/2020 dated 03rd March 2020	25	hSenid Business Solutions	Shenzhen kangzhan communication electronics Co., Ltd, China	02.06.20
		USD 1541.00
98	Infrared Thermometers	Invoice No. SUP20200420 dated 20th April 2020	50	Hummingbird International (PVT) Limited	Henan Bingzun lndustrial Co., Ltd. China	16.06.20
		USD 1450.00
99	Infrared Thermometers	Invoice No. Z360B dated 20th May 2020	1000	Imedra Healthcare (Pvt) Ltd	Ningbo Shangcun Electronic Co., Ltd., China	17.06.20
		USD 22000.00
100	Infrared Thermometers	Invoice No. 1079071825 dated 03rd June 2020	60	Jagath Kulunuguna	Guizhou Xinhui Optoelectronic Technology Co., Ltd. China	19.06.20
		USD 810.00
101	Infrared Thermometers	Invoice No. 20WT0431 dated 20th May 2020	500	Kamsons Trading Company (Pvt) Ltd	Shenzhen Changkun Technology Co Ltd. China	25.06.20
		USD 11950.00
102	Infrared Thermometer	Invoice No. H12YB20011 dated 26th April 2020	100	Lancor Rubber Industries	Shenzhen Ruiankang Technology Co., Ltd., China	01.06.20
		USD 3350.00
103	Infrared Thermometer	Invoice No. PI20200401-LK06 dated 26th May 2020	200	Lanka Tiles PLC	Guangdong Stable Medical Technology Co. Ltd. China	02.06.20
		USD 7200.00
104	Infrared Thermometer	Invoice No. CELCN2020SRI dated 18th April 2020	1000	Mel Wood International	Guangzhou Tida Electronic Technology Co Ltd. China.	16.06.20
		USD 10000.00
105	Infrared Thermometers	Invoice No. EI20052101002TH dated 23th May 2020	2	Metropoliton Office (Pvt) Ltd.	Zhangye Nuoan Medical Equipment Co., Ltd. China	22.06.20
		USD 44.00
106	Face Recognition Thermometer	Invoice No. LE200326 dated 26th March 2020	1	Metropoliton Office (Pvt) Ltd.	Shenzhen Shinyloam Electronics Co Ltd, China	01.07.20
107	Infrared Thermometer	Invoice No. CC2005060401 dated 25th May 2020	50	Monali Traders	Xuchang Chicheng Electric Co., Ltd. China	02.06.20
		USD 1575.00
108	Infrared Thermometer	Invoice No. GS20200603 dated 03rd May 2020	600	Nobel Traders	Guizhou Xinhui Optoelectronic Technology Co Ltd. China	11.06.20
		USD 8871.00
109	Infrared Thermometer	Invoice No. HJQ2020051908 dated 19th May 2020	1000	Orient Global Logistics Pvt Ltd	Fuzhou Meirun Medical Device Technology Co Ltd. China	02.06.20
		USD 12000.00
110	Infrared Thermometer	Invoice No. H12YB20011 dated 03th May 2020	26	Miss Oshika Peiris	Quality Technology Industrial Co. Ltd., China.	01.06.20
		USD 604.50
111	Infrared Thermometers	Invoice No. 2020/56 dated 24th May 2020	540	Paper Corner	Hunan Wei Ding Information Technology Co. Ltd. China	18.06.20
		USD 4800.00			Shenzhen Everbest Machinery Industry Co. Ltd. China
112	Infrared Thermometer /	Invoice dated 04th May 2020	5000	PCL Solutions (Pvt) Ltd	Shenzhen Bless Electronic Technology Co. Ltd, China.	07.07.20
		USD 9000.00
113	Infrared Thermometer	Invoice No. LINK2020API dated 11th April 2020.	100	PhiloBiotics Private Limited	Alicn Medical (Shenzhen), Inc. China	02.06.20
		USD 4540.00
114	Infrared Thermometer	Invoice No. JG20200528-014.	12	RCS2 Technologies (PVT) Limited	Shenzhen Qiangwei Electronic Co., Ltd. China	09.06.20
		USD 1057.00
115	Infrared Thermometer/ Goggles/ Face Shield/ Gloves	Invoice No. 88537 dated 20th May 2020		Rio Marketing (Pvt) Ltd	Shenzhen Qiangwei Electronic Co., Ltd. China	15.06.20
116	Infrared Thermometers	Invoice No. BIOBASE2020 0512 LK dated 12th May 2020.	100	S & D Associates	Guangzhou Sunray Medical Apparatus Co., Ltd. China	25.06.20
		USD 4000.00
117	Infrared Thermometer	Invoice No. 20WIN-T585JEP dated 26th May 2020	1002	S J Enterprises Pvt Ltd	Hunan Honggao Electronic Technology Co. Ltd. China.	03.06.20
		USD 6900.00
118	Infrared Thermometer	Invoice No. 019912 dated 20th May 2020.	252	S & S Trading	Chongqing Guiguzi Medical Technology Co. Ltd. China.	02.06.20
		USD 5800.00
119	Infrared Thermometer	Invoice No. SS20200519 dated 19th May 2020.	200	S & S Trading	Harbin Xiande Technology Development Co., Ltd. China	11.06.20
		USD 3200.00
120	Infrared Thermometer	Invoice dated 27th May 2020.	4	Samson Engineers Pvt Ltd	Shenzhen Medek Bio Medical Co Ltd. China.	01.06.20

121	Infrared Thermometers	Invoice No. FJ200522 dated 22nd May 2020.	30	Scientific Instruments (Pvt) Ltd	Shenzhen Zhengkang Technology Co Ltd. China	25.06.20
		USD 898.00
122	Infrared Thermometer	Invoice No. MC20200527R dated 27th May 2020.	100	S.E.A.P.L. Automation Systems (Pvt) Ltd	Guangzhou Sunray Medical Apparatus Co., Ltd. China.	26.06.20
		USD 1715.00
123	Infrared Thermometer	Invoice No. 202004008 dated 27th April 2020.	100	Senarathne Holdings Pvt Ltd	Shenzhen LeZhongxing Technology Co., Ltd. China.	02.06.20
		USD 985.00
124	Infrared Thermometer	Invoice No. ARH200428C dated 28th April 2020.	50	Sitech Engineering Solutions Pvt. Ltd	Penrui Biotech Inc, China	25.06.20
		USD 1750.00
125	Infrared Thermometers	Invoice No. 20SMR0426LK dated 28th April 2020.	40	Sky Elevator Tech (Pvt) Ltd	Zhengzhou AiQURA Intelligent Technology Co., Ltd., China.	17.06.20
		USD 1760.00
126	Infrared Thermometers	Invoice No. SON20200429A	360	Skyray Associated	Guizhou Tekang Electronic Co., Ltd., China.	01.07.20
		USD 6400.00
127	Infrared Thermometers	Invoice No. ES20200521577KL dated 25th May 2020.	16541	Softlogic Computers Pvt Ltd	Shenzhen Estar Technology Group Co. Ltd (HQ), China	03.06.20
		USD 281200.00
128	Infrared Thermometer	Invoice No. XST-A-20200631-KE-001 dated 26th May 2020.	2	Softlogic Computers Pvt Ltd	Hunan Honggao Electronic Technology Co., Ltd. China.	02.06.20
		USD 36.00
129	Infrared Thermometers	Invoice No. PS00514 dated 14th May 2020.	160	Star Garments (Pvt) Ltd.	Kunming Far Stars Diamond Craft Co. Ltd. China	20.06.20
		USD 4800.00
130	Infrared Thermometers	Invoice No. 2020040001 dated 21st April 2020.	240	Healthguard Pharmacy Ltd	Shenzhen Bless Electronic Technology Co. Ltd, China.	07.07.20
		USD 14400.00

131	Infrared Thermometer	Invoice No. ZZDF-20200509-03 dated 9th May 2020.	1008	TECHNIP Engineering Company	Zhejiang Mondial Electronic Technology Ltd. China.	26.06.20
		USD 24780.00
132	Facial Scan Camera with Temperature	Invoice No. LKSJZ20200507 dated 07th May 2020.	5	Toppan forms Colombo Limited	ShenZhen Lean Kiosk Systems Co., Ltd, China.	25.06.20
	Control System	USD 4440.00
133	Infrared Thermometer	Invoice No. 20KNS0507 dated 07th May 2020.	1020	Transco Marketing Pvt Ltd	Zhongshan Jinli Electronic Weighing Co., Ltd. China.	02.06.20
134	Infrared Thermometer	AW Bill No. 5194576435 dated 26th May 2020.	50	Wayamba Technical College of Halpara Junction	Harbin Xiande Technology Development Co., Ltd, China.	26.06.20
		USD 1300.00

List of issued WORs for PCR kits

*PCR test kits*
Applicant	Product	Manufacturer/ Supplier	Date Received	WOR issued date	Quantity	Invoice Number
Ministry of Health	Covid 19 Nucleic acid diagnostic kit for RT PCR test	China Sinopharm International Corporation - China	28.03.2020	28.03.2020	42 boxes	SPINTL20-TY007LK-1)
Asiri Surgical Hospital	Z- path 2019 n cov std Genesig Standard Kit Real Time PCR detection kit for 2019-nCoV	Primer Design Limited, UK	18.03.2020	18.03.2020	03 kits	0000601657
Nawaloka Hospital	New Corona Virus-2019 nCo nucleic acid detection kit	Shanghai GeneoDx Biotech Ltd, China	10.03.2020	18.03.2020	20 boxes (50 tests/box)	20200316
Microtech Biological (Pvt) Ltd,	VIASURE SARS -CoV-2 Real Time PCR Detection kits	Certest Biotec SL - Spain	19.03.2020	26.03.2020	2 kits	2030021
			12.05.2020	20.05.2020	10 kit	E20/2020397
			22.06.2020	25.06.2020	75 + 26	PROF- 20/2000584 PROF- 20/2000585
Avon Pharmo Chem (Pvt) Ltd,	Altona RealStar SARS – CoV -2 RT PCR Kit 1.0	Altona Diagnostics GmbH-Germany	18.03.2020	26.03.2020	40 kits	A20-01656
			08.04.2020	26.04.2020	15 +25 kits	R+ 20002356 & A20-02322
			27.04.2020	30.04.2020	50 kits	A20-02630
			12.05.2020	28.05.2020	200 kits	A20-02997
George Stuarts Health (Pvt) Ltd	IVD Real Time Detection Test Kit (PCR) (Standard M nCov Real Time Detection Kit	SD Biosensor, Inc. Korea	19.03.2020	25.03.2020	10 kits	KMI200317-2
Sunshine Healthcare (Pvt) Ltd	PCR Kit for detecting of SARS-COV-2 of RdRp. Gene and Sarbecovirus of E gene (LabGun COVID -19 Assay)	Labgenomics Co. Ltd, Korea for Siemens Healthcare , India	02.04.2020	17.04.2020	10 kits	EQL-3006731441
Biomedite (Pvt) Ltd	1 copy COVID-19 qPCR Multi Kit	1 Drop Inc, Korea	10.04.2020	29.04.2020	10 kit	Invoice : PI-200327
	GeneFinder Covid-19 Plus RealAmp	Osang Healthcare Co. Ltd, Korea	10.04.2020	21.05.2020	10 kits	INF_200329-02
	GeneFinder Covid-19 Plus RealAmp	Osang Healthcare Co. Ltd, Korea			20 kits	INF_200609-02
Dowell Medico (Pvt) Ltd	Quanti virus SARS Cov-2 test	Diacarta Inc, USA	25.04.2020	26.04.2020	100,000	(Invoice :SL-DM-MPFI-20/01)
Intergen Ltd	Genesig® COVID-19 assay (2019- nCoV)	Primer design , UK	31.03.2020	11.05.2020	04 kits	0000700993
HTIS Lanka Pvt Ltd	Accupower Covid 19 Real Amp Kit	Bioneer Corporation -Korea	28.04.2020	01.05.2020	01 box	IME-CI-200424-02
HTIS Lanka Pvt Ltd	Accupower Covid 19 Real Amp Kit	Bioneer Corporation -Korea	28.05.2020	01.05.2020	20 kits	IME- CI- 200520-01
Procare Holdings (Pvt) Ltd	Allplex 2019-nCov assay	Seegene Inc, Korea	27.04.2020	04.05.2020	7 kits	C-200422023
			20.05.2020	28.05.2020	30 kits	20200518
			05.06.2020	16.06.2020	125kits+ 125 kits	2020060201 and 2020060202
BELA International (Pvt) Ltd	Powercheck 2019-nCov Real Time PCR Test Kit	Kogene Biotech Co. Ltd, Korea	04.05.2020	06.05.2020	1 kit	KB20200429_2
Ministry of Health	Novel Coronavirus(2019-nCov) Nucleic Acid Diagnostic Kit(PCR- Fluorescence probing)	China Sinopharm International Corporation , China	09.05.2020	09.05.2020	30000 tests	SPINTL 20- TY 027AS-LK-1
Ministry of Health	Covid -19 Rapid test kits	Through MSD	08.05.2020		1000kits	No: 278 (File No: CHI/Mis/2020)
Elshaddai Enterprises	New Coronavirus Covid -19 Nucleic acid detection kit (Fluorescent RT –PCR method)	HunanRumMeiGene TechnologyCo.Ltd,China	29.04.2020	11.05.2020	1350 tests	RM-2020-4-15-05
Apcot Marketing (Pvt) Ltd,	iAMP Covid-19 detection kit	Atila Biosystem Inc, USA for Fujirebio Europe N.V., Belgium	09.05.2020	23.05.2020	500 (100 T)	5010038400
HTIS Lanka Private Limited	Accupower Covid- 19 Real time PCR kit	Corporation, Korea	01.06.2020		20 kits	IME- CI- 200520-01
United Nations Development Programme office in Sri Lanka	Novel Coronavirus (2019-nCov) nucleic acid diagnostic kit and QIAamp viral RNA mini kit	Sansure Biotech Inc, China and Qiagen , Germany	08.06.2020	18.06.2020	417 kits	202000679
Prime Minsiters Office , Sri Lanka	PCR test kits for Covid-19	Micro Biomed , Korea	22.05.2020	30.06.2020	6 kits	MBM20P01-530
Canoe Medicare (Pvt) Ltd	Dignovital Covid - 19 Detection Kit (SARS- Cov – 2 Realtime PCR kit 100 Test CE- IVD)	RTA Laboratories Biological Products Pharmaceutical and machinery Industry.	24/08/2020
Procare Holdings Pvt Ltd	RT PCR Kits	Seegene Inc. Korea	26/10/2020
Ceyoka Pvt Ltd	Accupower SARS – CoV – 2 Multiplex Real – Time RT- PCR Kit	Bioneer Corporation - Korea	27/10/2020
George Stuart Health Pvt Ltd	Real Time PCR for IVD test with qualitative analysis COVID – 19 Test Kit Accessories	SD Biosensor Inc. Korea	26/10/2020
Medical Supplies Division	Real-Time RT-PCR Kit and Liquid Handling Worksatation	BGI Health HK Company Limited	13/11/2020
Pro Care Holdings Pvt Ltd	RT PCR Kits	Seegene Inc. Korea	06/10/2020
Shield Medical Pvt Ltd	Covid – 19 Real Time PCR K it	Hong Kong Hybribio Ltd – Hong Kong	31.12.2020
Shield Medical Pvt Ltd	Covid – 19 Real Time PCR Kit	Hong Kong Hybribio Limited – Hong Kong	19/05/2021
Microtech Biological Pvt Ltd	VIASURE SARS – COV – 2 & UK Variant Real Time PCR Detection Kit	Certest Biotec SL - Spain	17/05/2021

List of issued WORs for Pulse Oximeter

Name of Importer

Name of Manufacturer

Brand/Model

Digital Cells (Pvt) ltd

Shenzhen IMDK Medical Technology Co, Ltd – China

iMDK C101A2 – OLED

Qty – 15,000

Digital Cells (Pvt) ltd

Shenzhen IMDK Medical Technology Co, Ltd – China

iMDK C101A2

Qty – 105,000

Mega Meditech (Pvt) ltd

Zhuhai Linte Medical Instrument Co, Ltd – China

Lintemed LT F20

Qty – 1000

George Steuart Health

Shenzhen Lepu Intellight Medical Equipment Co. ltd – China

Lepu LOX100A

Qty - 1000

George Steuart Health

Shenzhen Lepu Intellight Medical Equipment Co. ltd – China

LOX100C

Qty- 1000

George Steuart Health

Shenzhen Lepu Intellight Medical Equipment Co. ltd – China

LOX100A

Qty- 1000

Total Qty

124,000

Waiver of Registration Approved List – Device (September 2021 to December 2021)

Waiver of Registration Approved List – Device (September 2021 to December 2021)

	Date of Submission	NMRA Ref: Number	Item	Qty	Applicant	Manufacturer/Supplier	Reason for WOR	Remarks	WOR Committee Approval
1	25/08/2021		Freund's Adjuvant	5	University Of Jaffana	Sigma Aldrich - Germany	For Research Purpose	New model.	Recommended only for this consignment.
2	25/08/2021		Sperm Analyzer with Standard Accessories, Spare parts and reagents	1	Anlytical Instruments Pvt Ltd	M.E.S Ltd - Israel			Recommended only for this consignment
3	25/08/2021		Pulse Oximeter (TD - 8255)	500	Mega Meditech (Pvt) ltd	TaiDoc Technology Corporation - Taiwan	Due to the current Covid - 19 pandemic in the country and shortage in the market	Manufacture already registered with local agent certificate issued by Health Authority - Taiwan, EC Certificate, ISO Certificate are available.	Recommended and issue WOR for 02 Samples.
4	25/08/2022		Ultrasound Imaging System	1	Biomed International Pvt Ltd	GE Vingmed Ultrasound AS - Norway		Item already registered and has valied registration (D/2358). WOR requesting to import spare parts which are manufactured at different site.	Recommended only for this consignment
5	25/08/2023		Lab Reagents	1	Medical Research Institiute	VWR International GMBH - Austaria	Humanitarian donation by WHO		Recommended only for this consignment
6	27/08/2021		Antigen Rapid Test Kit	75	Mahamewna Maha Viharaya	Pradeep Chamil Wanniarachchige - UK	Personal Use of the monk Mahamewnawa Monastery		Recommended only for this consignment
7	30/08/2021		PPE Kits	300	Rotary Club of Kandy	Rotary Australia World - Castle Hill, NSW 2154	Donation	Donation from Rotary Australia	Recommended only for this consignment
8	31/08/2024		Covid 19 Anti Rapid Test (ART) Self - Test Kits (Brand : PANBIO)	03 (Pulse Oximeter) 10 (	Tea Tang (Pvt) ltd	Abotte Rapid Diagnostics Jena GMBH - Germany	Fro Release the items from Sri Lanka Customs.		Panbio Antigen Rapid Kits are registered. Recommended 03 Pulse Oximeter use for only personal.
9	1/9/2021		Vantilatior Machine	1	Medical Supplies Division	Jocelyne Rojas - United States	Donation	Donation but in the invoice it is mention has Commercial Purpose	Recommended only for this consignment and advice to submit to be validated by an end user.
10	1/9/2021		Covid 19 Test Kits (Model : FANABOI)	25 Test Kits	Hyosung Heavy Industries Corporation			For internal use by the corean Company	Recommended WOR allowed only for personal use.
11	1/9/2021		HLA Reagents		Emar Pharma Pvt Ltd	One Lambda – USA		Machine Specially 3 agent and manufacture registered with NMRA. In Aril 2021 also WOR Issue.	Recommended only for this consignment and need to be registered for future supply and expedite registration.
12	9/9/2021	MD/03/09/2021	CAP EQA test Kits		Bio Medica (Pvt) ltd	College of American Pathologists - America		For external quality assurance Programme of the Lab.	Recommended only for this consignment and advice to submit Invoice.
13	9/9/2021	MD/04/09/2021	Duodeno Videoscope (Model-TJF-150)	1	Mediquipment Limited	Olympus Medical System Co. - Japan	For Provincial General Hospital - Badulla	Repaired item	Recommended only for this consignment.
14	9/9/2021	MD/06/09/2021	Laboratory Specimens	N/A	Lanka Hospital Diagnostics (pvt) ltd	College of American Pathologists - America	External Quality Assuraance		Recommended only for this consignment.
15	13/09/2021	MD/16/09/2021	Antigen Rapid Test Kits	5000	Junaht International Pvt Ltd	Biolidics Limited - Singapore		New Manufacturer	Not recommended and advice to register the product.
16	16/09/2021	MD/25/09/2021	Blood Glucose Test Strip	2	Nagananda International Institute for Buddhist Studies	M/S Lin - Thaiwan	Personal Use		Recommended only for this consignment.
17	16/09/2021	MD/26/09/2021	10 Tubes (5 dried plasma Samples and 5 buffer)	10	National STD/AIDS Control Programme		For NSACP		Recommended only for this consignment.
18	17/09/2021		Pulse Oximeter		CT Trading Company	Shenzhen IMDK Medical Technology Co.ltd - China			Recommended.
19	17/09/2021		Auto-Disable Syringes 0.5ml		SPC	Hi—Tech Medical Private ltd - India			Recommended Only for this consignment.
20	24/09/2021	MD/41/09/2021	Humidifier	1	Dinesh Dharmadasa	CUI ZOU - China	For Custom Clearance	Not commercial value.	Recommended. As per the recommendation of the secretory, State ministry allowed only for this consignment.
21	24/09/2021	MD/49/09/2021	Root Canal Cement	10	Dilshan De Silva	Septodont - France	For Custom Clearance	New Manufacturer.	Recommended only for this consignment.
22	24/09/2021	MD/50/09/2021	Vedio Bronchoscopes and Colonoscope	3	Mediquipment Limited	M/S Olympus Medical System Co. - Japan	For Teaching Hospital Peradeniya and Lady Ridgway Hospital	Re import of Repaired item.	Recommended only for this consignment.
23	28/09/2021	MD/136/09/2021	Oxygen Flowmeter	10	Medilon Equipment (pvt) ltd	Jinhua Starcare Medical Supplies Co.ltd - China	Donation to Government Institute.	New manufacturer	Recommended only for this consignment.
23	28/09/2021	MD/136/09/2021	Non-Breathing Oxygen Mask	1,000	Medilon Equipment (pvt) ltd	Jinhua Starcare Medical Supplies Co.ltd - China	Donation to Government Institute.	New manufacturer	Recommended only for this consignment.
			Air Flometer	80		Jinhua Starcare Medical Supplies Co.ltd - China
			Flow Control Value Oxygen Concentrator	5		Jinhua Starcare Medical Supplies Co.ltd - China
			Oxygen Flowmeter with Humidirier	50		Jinhua Starcare Medical Supplies Co.ltd - China
24	28/09/2021	MD/137/09/2021	Anticoagulant Solution 500ml		Emar Pharma (pvt) ltd	Heamonetics S.A. - Switzerland	SPC Tender	New Manufacturing Site of an already registered product with NMRA.	Recommended only for this consignment and advised to submit the dossier.
25	28/09/2021	MD/138/09/2021	Consumables for Stem Cell Harvesting Kits		Apcot Marketing (pvt) ltd	Maco Pharma Rue Lorthiois 59420, Mouvaux - France	For National Blood Tranfusion Service (NBTS)	manufacturer already registered with this local agent. At present no registered supplier.	Recommended only for this consignment.
26	24/09/2021	MD/64/09/2021	Oxygen Generator	1	Pelemix Lanka (pvt) ltd, 115/1/1, Jawatta Road, Colombo 05	N/A		Donation from Head Office to Sri Lankan Branch.	Recommended only for this consignment.
27	30/09/2021	MD/150/09/2021	Spinal Board / Dental Chair / Digital BP Aperator / Televesion / Spot Lamp / Stethoscope / ECG Machine / Delivery set Suture set / Nebulizer Machine / Sucker Machine	18	Management and Advisory Committee of Proposed World Heritage Site of Seruwila Raja Maha Viharaya for UNESCO	Sri Lanka National Commission for UNESCO	For Seruwila Rural Hospital	Donation DH Seruwila	Recommended only for this consignment.
28	30/09/2021	MD/153/09/2021	FACS Presto Cartridge Kits	11	National STD/AIDS Control Programme	BD International - Belium	Donation to STD		Recommended only for this consignment.
29	30/09/2021	MD/163/09/2021	GXHIV-1-CE-10 Kit, 10 Test, HIV QUANT CE IVD	28	National STD/AIDS Control Programme	Cepheid - France	Donation		Recommended only for this consignment.
30	30/09/2021	MD/175/09/2021	Lab Regents (Cell Culture, L-Glutamine) / Cell_Culture / L_Glutamine	3	Medical Research Institute	VWR International GnbH - Malaysia	Donation	Donation to MRI	Recommended only for this consignment.
31	30/09/2021	MD/178/09/2021	Fingertip Pulse Oximeter (A2) / N95 Mask	Oximetr - 40 / N95 Mask 60	Amila Welendagoda	Shenzhen IMDK Medical Technology Co.ltd - China	Donation	New Manufacturer	Recommended only for this consignment.
32	30/09/2021	MD/181/09/2021	Face Shield / Face Mask Disposable / Sport Mask . Kids Masks	382	Medical Supplier Devision	SymplyHelp - USA	Donation		Recommended only for this consignment.
33	24/09/2021	MD/38/09/2021	Dental Accessories / Composites		PCL Solutions (Pvt) ltd	DMP Dental Industry S.A - Greece	Already recommended in the Committee Held on 23/08/2021		Recommended only for this consignment.
34	30/09/2021	MD/152/09/2021	Super Snap x-trme technique mini kit for finishing and polishing composite restoration	6,500	Ogaki & Company	Shoufu Inc - Japan	Submitted to WOR Committee held on 23/08/2021 and to WOR committee held on 17/09/2021 and committee decision was SPC Tender documents not available and register the product.		Recommended only for this consignment.
35	30/09/2021	MD/113/09/2021	Q.E.D.A.150 Saliva Alchol Test	1300	George Steuart Health (Pvt) ltd	Orasure Technologies Inc - USA	Submitted to WOR Committee held on 23/08/2021 and Not Recommended and again appeal submitted committee held on 17/09/2021 and Advised to submit recommendation from college of Forensic Pathologists of Sri Lanka. (Document Submitted)		Recommended only for this consignment and.
36	30/09/2021	MD/170/09/2021	Paste Carriers	5700	SS Dento Pharma	Mani Inc - Japan	Submitted to WOR Committee held on 03/09/2021.		Recommended only for this consignment. Indent Number: LP/DHS/S/WW/138/660AM/19
37	30/09/2021	MD/151/09/2021	Integrated Dental Unit	03	Dent Re	Guangdong Yodeng Medical Apparatus Co.ltd - China		For Dental	Recommended only for this consignment.
38	6/10/2021	MD/206/10/2021	Portable Eternal Feeding Pump with accessories / Eternal Feeding Pump Giving set.	15 + 60	A. Baur & Co. (pvt) ltd	Azium Mtech SA - Switerland	For Three Government Hospitals	Already registered Product. (D697NP / D1118NP) Manufacturing Site Change.	Recommended Only for This Consignment. And for future supply product need to be registered with NMRA.
39	6/10/2021	MD/213/10/2021	Reagents for Hematology Analyzer (MEK-680)	30	Hemas Surgicals & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Hospital	Already restered product full registration expierd reasonly and A/T to Hemas. (File No DVR 9928)	Recommended only for this consignment and submit file for renewal of registration.
40	4/10/2021	MD/246/10/2021	Reagents Calibrators & Controls for Hematology Analyzer	40	Hemas Surgicals & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Government Office	Re agent wich are mention in the invoice not taly with registration certificates. (Model is different). A/T product from tmi Solution to Hemas.	Can be Recommended if a copy of registration document for the specific model is provide.
41	14/10/2021	MD/262/10/2021	Laser Medical Thermometer	202	U.G.K. Nilmini	Bella (Guangzhou) Intelligent Information Technology Co.ltd - China	Donation for the Godakawela Pradeshiya Sabha		Recommended only for this consignment.
42	14/10/2021	MD/263/10/2021	PCR Test Kit	6	S. Thiruvarudkumar	Minako Taskilan Glattsting - Switzerland	Personal Use		Recommended only for this consignment. Self-Testing PCR Kit send by a relative in overseas for personal of family.
43	12/10/2021	MD/264/10/2021	Easy Beat Egg	110	IY Marketing Services	UPS Singapore PTE Ltd - Singapore			Recommended only for this consignment.
44	14/10/2021	MD/269/10/2021	Electro Medical Equipment (Mindary)	20	Biomedica (Pvt) ltd	Shenzhen Mindray Bio- Medical Electronic Co.ltd - China		Re export to nepol	Recommended only for this consignment. Approval for export.
45	22/10/2021	MD/270/10/2021	Artificial Limbs	1,075	Meththa Rehabilitation Foundation Guarantee.ltd	The Meththa Foundation - UK	For Clinic	Donation for Row Material fabricating of artificial limbs.	Recommended only for this consignment.
46	22/10/2021	MD/271/10/2021	Machinery, Tools and Other Components		Colombo Friend - in - Need Society	Proactive Technical Orthopaedics (pvt) ltd - India		Donation for fabricating artificial limbs.	Recommended only for this consignment.
47	22/10/2021	MD/272/10/2021	LED PT Phototherapy System	1	Biomed International (pvt) ltd	Datex - Ohmeda Inc - USA	For Ruhunu Hospital Diagnostics	Spare parts are imported in Vietnam (one unit) for already registered Phototherapy System. (File DVR/12483)	Recommended only for this consignment.
48	22/10/2021	MD/273/10/2021	Regents, Solutions Used in NGS Machines		Credence Genomics (Pvt) Ltd	Thermofischer Scientific - USA	For Ion Torrent PGM and Gene Studio S5 Prime.	Limited quantity for research purpose.	Recommended only for this consignment. (For Research Purpose)
49	22/10/2021	MD/275/10/2021	Mini Autoclave (Spare Parts)	77	Mediquipment Limited	Eschamann Technologies Ltd - UK	Repaired Item	Registration expired in 2017, not apply for renewal. (DVR/9328)	Recommended only for this consignment.
50	22/10/2021	MD/278/10/2021	Artificial Hands	18	Colombo Friend - in - Need Society				Recommended only for this consignment. (OTC)
51	22/10/2021	MD/279/10/2021	Oxygen Concentrator	60	Access International (Pvt) ltd	Shenyang Canta medical Technology Co.ltd - China			Recommended only for Part of this consignment. Only for 10L/min Oxygen Concentrator. (Qty-20 Pcs) Model: V5-WN-NS Brand - Canta.
52	22/10/2021	MD/280/10/2021	Oxygen Concentrator	3	Ruby Plastic (Pvt) ltd	Shenzhen Deda Health Co.ltd - China	For Personal Use		Recommended only for this consignment.
53	28/07/2021	-	Bull Nose Oxygen Regulator	320	Access International Pvt Ltd	Dangyang Airtech Co.Ltd - China	For Covid Centers	07/08/2021 Committee Decision: Issue WOR only for 02 Samples. Need to submit samples for evaluation	Sample evaluated and recommended only for this consignment and for future supply product need to be registered with NMRA.
54	10/09/2021	MD/21/09/ 2021	Medical Oxygen Regulator	500	Ovin Gases (pvt) ltd	Ningbo MFLAB Medical Instruments Co.ltd - China	For Hospitals		Sample evaluated and recommended only for this consignment and for future supply product need to be registered with NMRA.
55	02/07/2021	-	Oxygen Regulator	1000	Nevena Importers	Danyang Airtech Co Ltd - China	-	07/08/2021 Committee Decision: Issue WOR only for 02 Samples. Need to submit samples for evaluation	Sample evaluated and recommended only for this consignment.
56	8/9/2021		Oxygen Concentrator (10L)	200	Access International (Pvt) ltd	Shenyang Canta Medical Tech. Co.ltd - China	For Covid Centers		Sample evaluated and recommended only for this consignment. (10L/min Oxygen Concentrator only) Model: V5-WN-NS Brand - Canta.
57	15/09/2021	MD/66/09/2021	Oxygen Concentrator	150	Delmege Forsyth & Co.ltd	Jiangsu Folee Medical Equipment Co.ltd	For Covid Patient		Sample evaluated and recommended only for this consignment. For future supply product need to be registered with NMRA.
58	17/09/2021	MD/98/09/2021	Fingertip Pulse Oximeter	1000	Pasific Trading Company	Yibin Junxin Electronics Technology - China			Sample evaluated and recommended only for this consignment. for future supply product need to be registered with NMRA.
59	06/09/2021		Fingertip Pulse Oximeter	2000	George Steuart Health (Pvt) ltd	Shanghai Berry Electronic Tech Co.ltd - China	Commercial Purpose		Sample evaluated and recommended only for this consignment. for future supply product need to be registered with NMRA.
60	06/09/2021		Fingertip Pulse Oximeter	3750	Sunway Healthcare (pvt) ltd	M/s Vizin India (Pvt) ltd - India	Commercial Purpose		Sample evaluated and recommended only for this consignment. For future supply product need to be restarted.
61	30/09/2021	MD/145/09/2021	N95 Surgical Respirator (Niosh Standerd)	1,875	Sisili Projects Consortium (pvt) ltd	Rizhao Sanqi Medical & Health Articles Co.ltd - China		Submitted to WOR Committee held on 01/10/2021 and Committee Decision was the policy of government of Sri Lanka, need clarification from secretory, State ministry for consider grating waiver.	Recommended only for this consignment. For future supply product need to be registered with NMRA.
62	30/09/2021	MD/146/09/2021	N95 Surgical Respirator (Niosh Standerd)	75,000	Sisili Projects Consortium (pvt) ltd	Rizhao Sanqi Medical & Health Articles Co.ltd - China		Submitted to WOR Committee held on 01/10/2021 and Committee Decision was the policy of government of Sri Lanka, need clarification from secretory, State ministry for consider grating waiver.	Recommended only for this consignment. For future supply product need to be registered with NMRA.
63	30/09/2021	MD/147/09/2021	N95 Surgical Respirator (Niosh Standerd)	100,000	Sisili Projects Consortium (pvt) ltd	Rizhao Sanqi Medical & Health Articles Co.ltd - China		Submitted to WOR Committee held on 01/10/2021 and Committee Decision was the policy of government of Sri Lanka, need clarification from secretory, State ministry for consider grating waiver.	Recommended only for this consignment. For future supply product need to be registered with NMRA.
64	24/09/2021	MD/52/09/2021	1. Spare Parts and Accessories for Defibrillators. 2. Spare Parts and Accessories for Patient Monitors (Model: life scope / Dismo)		Hemas Surgical & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Hospital	Submitted to WOR Committee held on 01/10/2021 and Committee Decision was Need Legal Advice.	According to given legal advice, recommended only for this consignment. For future supply product need to be registered with NMRA.
65	30/09/2021	MD/134/09/2021	3M N95-1860 Fce Mask	100,000	Cloud Healthcare (pvt) ltd	3M Vietnam Limited - Vietnam	SPC Tender	Submitted to WOR Committee held on 01/10/2021 and Committee Decision was the policy of government of Sri Lanka, need clarification from secretory, State ministry for consider grating waiver.	Recommended only for this consignment. For future supply product need to be registered with NMRA.
66	26/10/2021	25/10/2021/002	Injection Syringe Pumps (Model:SP95)	5	Mr. M.I. Wijegooneratne		Donation to Ragama Hospital		Recommended only for this consignment.
67	27/10/2021	18/10/2021/003	Reagents Calibrators & Controls for Hematology Analyzer	600	Hemas Surgical & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For Office of Provincial Director of Health Services		Recommended only for this consignment.
68	27/10/2021	18/10/2021/004	Spare Parts for Patient Monitor	15	Hemas Surgical & Diagnostics (Pvt) ltd	Nihon Kohden - Japan	For DGH - Polonnaruwa		Recommended only for this consignment.
69	27/10/2021	18/10/2021/014	Spare Parts and Accessories for defibrillator	12	Hemas Surgical & Diagnostics (Pvt) ltd	Nihon Kohden - Japan			Recommended only for this consignment.
70	2/11/2021	MD/314/11/2021	AC-CCR Flow Cast Basophil Activation Test Flow Cytometry and Allergens	One Each	HighChem R Ceylon Company (Pvt) ltd	Buhlmann Laboratories - Switzerland	For Allergy, Immunology and Cell Biology Unit, University of Sri Jayewardenepura.	For research Purpose. New Manufacturer.	Recommended only for this consignment.
71	5/11/2021	MD/323/11/2021	KN95 / FFP2 Face Mask	200,000	Race Course Athletic Club	Shenzhen Allround Tech Limited	Donation Sports Club	New Manufacturer	Recommended only for this consignment. Need to Submit distribution List.
72	5/11/2021	MD/324/11/2021	Sturdy Container 2lt	42	National Programme for Tuberculosis Control & Chest Diseases.	GFATM	Donation to NPTCCD		Recommended only for this consignment.
73	9/11/2021	MD/331/11/2021	Oxygen Concentrator - Canta (10 L)	3	gsk - SmithKline Beecham (Pvt) ltd	Shenyang Canta Medical Tech. Co.ltd - China	For Factory Staff	New Manufacturer	Recommended only for this consignment. The same brand previous evaluated and approved. This is only for staff use only 3 unit and not for commercial purpose.
74	9/11/2021	MD/337/11/2021	Tattoo Cartridge Needles	100	R.J. Saman Kumara	Suzhou Huali Tattoo Needles - China		Listed Item	Recommended only for this Consignment.
75	9/11/2021	MD/338/11/2021	Spare Parts for Sterilizer System	18	Mediquipment Limited	Getinge Sterilization AB - Sweden	Repaired Items	Spare Parts for discontinue registered item. (DVR/11509)	Recommended only for this Consignment.
76	11/11/2021	MD/340/11/2021	Medical Equipments	74	Medical Supplies Division	United Nation Children Funds	Donation to MSD		Recommended only for this consignment.
77	11/11/2021	MD/341/11/2021	Gloves/Isolation gown/Masks (3ply) / Masks (KN95)	918	Medical Supplies Division.	Buddhist Union - Los Angeles	Donation to MSD		Recommended only for this consignment.
78	09/09/2021		Fingertip Pulse Oximeter (PC-60B1)	10,000	Instrumedic International (Pvt) ltd	Lepu Medical Technology (Beijing) Co.ltd-China	Commercial Purpose		Sample evaluated and recommended only for this consignment.
79	25/06/2021		Fingertip Oximeter (OLED Type)		George Steuart Health	Ath Inc - China			Sample evaluated and recommended only for this consignment.
80	11/11/2021	MD/342/11/2022	Medical Oxygen Concentrator / Medical Oxygen PSA (Model: OA 250-SK)	1	Adelaide Sri Lanka Buddhist Vihara Inc	Oxair Gas Systems - Australia / Oxair Gas Systems - India	Donation to Adelaide Sri Lanka Buddhist Vihara Inc	-	Recommended only for this consignment.
81	2/11/2021	MD/349/11/2021	Syringe Infusion Pump/Syringe pump with standard accessories (Perfusor Compact Plus)	200	B Braun Lanka (Pvt) ltd	B. Braun Melsungen AG - Germany	Export to repaired items	Export to repair Items.	Recommended only for this consignment.
82	10/11/2021	MD/350/11/2021	Lateral flow kit for family member with cancer	1	N.Raveendran	UK - Mainland	For personal Use	-	Recommended only for this consignment. (For personal use of cancer patient)
83	10/11/2021	MD/353/11/2021	Empty Hard Capsules Packing Pack (100%) Plastic / Hard Filling Machine Set	3	Co-Operative Hospital Society ltd - Moolai			-	Recommended only for this consignment. Issue product categorization.
84	19/11/2021	MD/357/11/2021	nTSH ELISA 20 Plate Kit	80	Medical Supplies Division	MP Biomedicals Asia Pacific Pte Ltd - United States of America	For MSD	Manufacturer Registered with NMRA.	Recommended only for this consignment.
85	19/11/2021	MD/358/11/2021	DELFIA nTSH (960T) Kit	120	Medical Supplies Division	PerkinElmer Singapore PTE Ltd - Finland	For MSD	Manufacturer Not Registered with NMRA.	Recommended only for this consignment.
86	1/12/2021	MD/379/12/2021	Oxygen Concentrator (Model:(OZ)-02-5-01GWO)	15	Tmi Solutions (Pvt) ltd	Guangdong Owgels Science and Technology Co.ltd- China	Sri Lanka Army Headquarters Purchase Order		Recommended. WOR allowed import only one unit for testing at BMES.
87	1/12/2021	MD/422/12/2021	Syringe Filter Unit, Sterile 33mm	200	Atlas Populi (Pvt) ltd	Merck KGaA, Darmstadt - Germany		Manufacturer Not Registered with NMRA.	Recommended only for this consignment. It is for research purpose and development purpose.
88	1/12/2021	MD/382/12/2021	Duodena Video Scope		Mediquipment Limited	Olympus Medical System Corporation - Japan	Repaired Items	-	Recommended only for this consignment.
89	1/12/2021	MD/400/12/2021	QIA Cube HT / QIAxtractor , Platform	1	Microtech Biological (Pvt) ltd	QIAGEN GmbH - Germany	For Health System Enhancement Project (To Apeksha Hospital, Maharagama)	Manufacturer already registered with Microtech Biological (Pvt) ltd.	Recommended only for this consignment.
90	22/11/2021	MD/403/12/2021	EXT120-U Ozone Generator		Rajarata University of Sri Lanka	Longevity Resources - Canada	For the study.	-	Recommended only for this consignment.
91	30/11/2021	MD/409/12/2021	Multifilter ate Machines	5	Fresenius Medical Care	Fresenius Medical Care - Rusia	To Re-Export	-	Recommended only for this consignment. (to export)
92	7/12/2021	MD/427/12/2021	Continuous Renal Replacement Therapy Device	1	Diligence Healthcare (pvt) ltd	Indomed SA - Switzerland	DGHS - Southern Province	Manufacturing site changed from Switzerland to Plant. Legal manufacturer is Same.	Recommended only for this consignment.
93	7/12/2021	MD/428/12/2021	Ventilator Spare Parts	2	Diligence Healthcare (pvt) ltd	Zoll Medical Corporation - USA		Manufacturer already registered with NMRA.	Recommended only for this consignment.
94	15/11/2021	MD/347/11/2021	Medical Equipment		University of Colombo	Thermofisher Scientific	Donation to University of Colombo	-	Recommended only for this consignment.
95	11/11/2021	MD/344/11/2021	Medical Equipments	17	Medical Research Institute	VWR International CmbH - Austria	Donation by WHO to MRI	-	Recommended only for this consignment.
96	22/11/2021	MD/354/11/2021	Respiratory Syncytial Virus Freeze dried powder in glass vial / Respiratory Syncytial Virus Controls dried powder in glass vial	14	Medical Research Institute	NEQAS - UK	Donation to MRI	-	Recommended only for this consignment.
97	22/11/2021	MD/355/11/2021	Voltage Stabilizer	312	Medical Supplies Division	United Nation Children Funds (UNICEF)	Donation to MSD	-	Recommended only for this consignment.
98	29/11/2021	MD/368/11/2021	Fingertip Pulse Oximeter	1,050	Medical Supplies Division	Guangdong Weishan Technology Co.ltd - China	Donationa to MSD	-	Recommended only for this consignment.
99	25/11/2021	MD/369/11/2021	Medical Equipments	162	Medical Supplies Division	UNICEF	Donation to MSD	-	Recommended only for this consignment.
100	11/11/12021	MD/345/11/2021	Laboratory Oven 256Lt, Laboratory Oven Shelves, A-Acetyl-L-Cysteine 100g	42	National Programme forTuberculosis Control & Chest Diseases	DE - Germany	Donation to NPTCCD	-	Recommended only for this consignment.
101	19/11/2021	MD/366/11/2021	Vitrification Solution Set 110 & Warming Solution Set 205-80 Sets / Cryotec (10 Pieces) - 100 Sets	80 + 100	Vindana Reproductive Health Centre (Pvt) ltd	Reprolife - Japan	For Assisted Reproductive Services	-	Recommended only for this consignment.
102	9/9/2021	MD/10/09/2021	Nucleic Acid Extraction Kit C32 test, 96 test)	100000	Avon Pharma Chem (Pvt) ltd	Zybio INC - China		Already file submitted and registration is recommended by Sri Lanka College of Microbiology. NMRA still not issued the certificate. Due to the agency transfer continue us discussion.	Recommended only for this consignment. (As per the letter given by the NMRA WOR.)
103	19/11/2021	MD/360/11/2021	Micromanipulation Pipettes (ICSI Pipettes / Holding Pipettes)	182	A. Baur & Co. (Pvt) ltd	Vitrolife Inc - USA	For Several Hospitals	Manufacturer Not Registered with NMRA. WOR issued on September	Recommended only for this consignment.
104	610/2021	MD/208/10/2021	Neogen Culture Media	12	Mediding (pvt) ltd	Neogen Corporation - USA	For Coconut Development Authority	-	Recommended. Issue Product Categorization.
105	6/10/2021	MD/218/10/2021	Oxygen Regulator	20	Gas Connect (pvt) ltd	Danyang Lovetec Value Co.ltdd - China			Recommended only for this consignment. Apply for registration. Sample tested by BMES and Pass.
106	6/10/2021	MD/214/10/2021	Oxygen Regulator	100	Silkroad Traders Hub (Pvt) ltd	Shenzhen Great Fruit Supply Chain Co.ltd - China	Donation for Several Hospitals		Recommended only for this consignment. Apply for registration. Sample tested by BMES and Pass.
107	17/09/2021	MD/70/09/2021	Oxygen Concentrator (DO2-5AH)	5	Medisurg International	Kunshan Dymmed Medical Technology Co.ltd	Staff use		Recommended only for this consignment and apply for registration. Sample tested by BMES and Pass.
108	7/9/2021		Oxygen Concentrator (Model- SD/05B, SD/05W)	100	PCL Solotions (Pvt) Ltd	Jiangsu Shuangsheng Medical Appliance Co.ltd - China			Recommended only for this consignment and apply for registration. Sample tested by BMES and Pass.
109	17/09/2021		Pulse Oximeter (Model-C101A2)	2000	Metro Serandib (Pvt) ltd,	Shenzhen IMDK Medical Technology Co.ltd - China			Recommended only for this consignment. Sample tested by BMES and Pass.
110	17/09/2021		Pulse Oximeter (Model-C101A2)	200	J.G.K. Kavinda Hashan	Shenzhen IMDK Medical Technology Co.ltd - China			Recommended only for this consignment. Sample tested by BMES and Pass.
111	17/09/2021		Pulse Oximeter (Model-C101A2)	200	T.H. Rasanga Laksri Tharuka	Shenzhen IMDK Medical Technology Co.ltd - China			Recommended only for this consignment. Sample tested by BMES and Pass.
112	6/9/2021		Pulse Oximeter (Reelom Oximeter - ROX-1111)	100000	Junaht International Pvt ltd,	Vizin India Pvt ltd- India			Recommended only for this consignment. Sample tested by BMES and Pass.
113	10/12/2021	MD/430/12/2021	Shipment Items		Ethics Review Committee, Facalty of Medicine, University of Colombo	Lajolla Institute of Immunology - USA			Recommended only for this consignment.
114	10/12/2021	MD/432/12/2021	Home Defibrillator		Lanka Jathika Sarvodaya Shramadana Sangamaya				Recommended only for this consignment.
115	11/11/2021	MD/351/11/2021	Spacer Device for Metered dose inhaler - AEROSPACER PLUS	120,000	Emerchemie NB (Ceylon) Limited	Taian Dalu Medical Instruments Co.ltd - China	SPC Order	Registration is valid until march 2022. WOR not necessary. (D/1356)	WOR not necessary at the product has valid registration.
116	1/12/2021	MD/391/12/2021	Ring Pessary	19,912	Thusitha Rajapaksha, Sunshine Healthcare Lanka Ltd	Cooper Surgical Inc - USA	SPC Order	-	Recommended only for this consignment. Allowed WOR approved to clear balance stock.
117	1/12/2021	MD/399/12/2021	Linear Cutter Device 100mm length,4.8mm height (Green) Sterile, Cartridges for Linear Cutter Device 100mm length, 4.8mm height (Green) Sterile)	666	A. Baur & Co. (Pvt) ltd	Covidien Pvt Ltd - USA	SPC Order	Agency transfer from Ceyoka (pvt) ltd to A. Baurs Co. (pvt) ltd is under processing. Not given by Ceyoka for agency transfer.	Recommended only for this consignment.
118	7/12/2021	MD/425/12/2021	Denture Flask & Clamp	27	Rivomed Holdings (Pvt) ltd	Silfradent Srl - Italy	SPC Order	Manufacturer not registered with NMRA.	Recommended only for this consignment. Product need to be registered as listed item for future supply.
119	8/11/2021	MD/309/11/2021	DNA Whole Blood Kit	54 Kits	Emar Pharma (Pvt) ltd	RBC Bio Science Corp - Taiwan	SPC Tender	Manufacturer not registered with NMRA.	Recommended only for this consignment.

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