To all importers / Local agents of medical Devices.

This is to bring to your notice, as there is a failure in the eNMRA digital platform, NMRA has decided to implement the following action plan in a step-by-step manner in order to cater to applicants whose requirements were previously processed through the online system and new applicants who wish to start registration until the system is restored.

1. Local agent profile creation

•This process is suspended temporally until the system is restored.

2. Applications for the approval of foreign manufacturing sites (Medical Devices )

• Applications submitted through online and which are at screening level and pending processing fee.

• Application (File) shall submit manually with the online evidence.


• Documents should be in the file as per NMRA guidelines already published in NMRA web site. In addition, manufacturer should provide a confirmation letter to the authority stating that there is no further local agent appointed.


• Local agent shall submit a consent letter to withdraw the application when the authority notice duplications and decide to withdraw the latest application as per reference number. (Files may be submitted to the authority by more than a local agent)


• Use only transparent plastic file covers for documentation.


• NMRA admin division will send the evaluation report via email to the company.

• Application submitted via online and which are at review level, approval after processing fee

• Application (Dossier) shall submit manually with payment evidence. (A verified payment reciept issued by the accounts department of NMRA shall enclose)


• Documents should be in the file as per NMRA guidelines already published in NMRA web site.


• In addition, Local agent should submit a confirmation letter stating that documents which are attached in the manual application is same as the online application.


• Use only transparent plastic file for documentation..


• NMRA admin division will send the evaluation report via email to the company.

• New application ( There is no online process)

• If a local agent wish to apply for registration of foreign manufacturing site, following steps to be followed.


• Manufacturer shall send the letter of appointment and a confirmation letter to CEO/NMRA stating that there is no further local agent appointed. Both documents to be submitted via email to legal department of NMRA to check the authenticity of appointment letter. It will be informed to Focal Point of MDR division through.


• Local agent shall submit application /file manually. Documents should be in the file as per NMRA guidelines already published in NMRA web site. Payment note for processing fee shall be issued by accepting pharmacists after the recommendation of focal point of MDR/Division.


• Use only transparent plastic file for documentation.


• NMRA admin division will send the evaluation report via email to the company.

Applications for foreign manufacturing site approval will be accepted on Tuesday from 9.00 a.m. to 3.30 p.m.

3. Applications for sample import licences of medical devices.

• NMRA will be accepted sample import license applications only for following products.

• For SPC tenders


• For DHS tenders


• Products essential for pandemic or emergency


• Monopoly items


• Change of manufacturing sites.


• Delay submission of for renewal due to pandemic situation etc.


• NMRA requests based on the recommendation of Committees.


• Novel medical devices


• New technology products manufactured or approved in a NMRA reference countries.


• There is no registered medical devices available in the market.

If a sample import license application has already been applied through eNMRA, a manual application shall submit with a copy payment receipt and approval of foreign manufacturing facility.

Applicant who has already applied for registration of foreign manufacturing site through online and which are pending, shall submit manual sample import license application after submitting manual application for registration of foreign manufacturing site and completed the relevant processing fee of foreign manufacturing site registration.

All new applications (Not applied through eNMRA) shall submit sample import license application after the approval of foreign manufacturing site. Approval of foreign manufacturing site shall submit with the sample import license application.

Applications for sample licences should be submitted to NMRA new premises located at No. 72 W. A .D Ramanayake Mawatha, Colombo 00200 on Mondays and Thursday from 9.00 a.m. to 3.30 p.m.

4. Registration of medical devices- New applications

• Application can be applied only for following products.

• For SPC tenders


• For DHS tenders


• Products essential for pandemic or emergency


• Monopoly items


• Change of manufacturing sites.


• Delay submission of for renewal due to pandemic situation etc.


• NMRA requests based on the recommendation of Committees.


• Novel medical devices


• New technology products manufactured or approved in a NMRA reference countries


• There is no registered medical devices available in the market.

Maximum 03 files / week will be accepted from a local agent.

The approval of foreign manufacturing site and copy of sample import license should be attached in the file.

If an application has already been applied through eNMRA, a manual application shall be submitted with a copy payment receipt and approval of foreign manufacturing facility.
Use box file covers for documentation.

Re-registration application will not be accepted until further notice. If re-registration application has already been applied through eNMRA, a manual application shall submit with a copy payment receipt and approval of foreign manufacturing facility.

 Applications will be accepted on Tuesday from 9.00 a.m. to 3.30 p.m.

5. Registration of medical devices – Renewal Applications

• NMRA will accept all re-registration applications manually (applications submitted through eNMRA and not submitted through eNMRA) for routine process.


• After reassessing the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to exempt the requirements specified under section 64 (1) of the NMRA Act for a limited time period when accepting of renewal applications. Therefore, if the expiry of existing registration certificate or expiry of extended registration certificate falls between 2nd September 2021 to 30th May 2022, Section 64 (1) of the NMRA Act No.05 of 2015 will not be considered when submitting the dossiers/documents for re- registration.


• With each application a copy of extended registration certificate & import license should be enclosed. A declaration shall be submitted by the applicant if previous registration was not extended.


• Applications will be accepted on Tuesday from 9.00 a.m. to 3.30 p.m.

6. Additional data / sample/ request for demonstration

• For the decision of “Awaiting data”, “Awaiting sample” and “Awaiting demonstration” will be accepted only within one year from the date of CEO’s approval of the latest evaluation.


• Applications will be accepted on Tuesday from 9.00 a.m. to 3.30 p.m.