gov lk

Responsibility of the Marketing Authorization Holder
Flow chart of registration process of medical devices is as follows

Steps involved for registration of medical devices

fig2 device


Submission of registration application



Documents for obtaining sample import license

Application for medical device registration

Submission of applications for Orthopedic Implants and Instruments

This is to inform you that Sri Lanka Orthopedic Association has submit a new guideline for classification of orthopedic implants and instruments for the purpose of submission of applications for sample import license and registration to NMRA (Annex 1). As such you should follow below mention procedure for submission of applications for orthopedic implants and instruments.

   Step 1 - Categorized the implants or instruments to main categories
               (i) Orthopedic implants or instruments
               (ii) Oral Maxillofacial (OMF) implants or instruments
               (iii) Neuro implants or instruments

     Step 2 - Classification of main group
              For orthopedic products separate dossiers to be submitted according to the classification for main six (6) groups.

     Step 3 - Classification of sub group

             Sub groups intended to register under each main group should be clearly categorized by the manufacturer based on the Free Sale Certificate.           

                          Eg: Main group - Adult plates and screws.

            Sub groups - Large fragment locking plates and screws, Mini fragment locking plates and screws, small fragment locking plates and screws.
            The NMRA will coordinate with the applicants those who has already submitted registration dossiers for re-arrangement according to the above      guideline requirements. 

Multiple Applications

A medical device consisting a collection of devices and has a common intended purpose is registered as a group.

Electro surgical unit with standard accessories (electrodes, electrode holders, leads, Plates, plug adopter)

Anesthesia machine with standard accessories

Nebulizer system

Data requirement for preparation of Medical Device application

General Documents/ Requirements

Fulfilled Schedule I, Form A & Form B

Technical Documents

Following documents should be submitted in addition to the basic documents where necessary / if available

Final product inspection report (for electro medical equipment and machines) and finished product test report for other products Submit relevant report issued by the manufacturer or third-party laboratory for batch release of the product

Test reports for below mentioned items

Material test report for sutures, medical instruments such as forceps, scissors etc.

Certification for quality management system according to ISO 13485 from authorized notified body in order to access the design, development, manufacturing as well as for post marketing monitoring of safety and performance of the manufacturer

CE accreditation from authorized notified body in order to prove the quality assurance system of the product and EC design examination certificate (if applicable)

Stability data for entire shelf life of the finished products should be provided (if applicable)

In addition, following requirements should be fulfilled for Absorbable sutures with the application

Details of the raw material sources, purchasing details should be provided

Where necessary certificate of approval from relevant authorities should be provided

For radiation emitting devices approval obtained from Atomic energy Authority of Sri Lanka

Certification from the relevant health authority of the country of manufacturer that the product is free from BSE (Bovine Spongiform Encephalopathy) should be obtained for animal derived products

Surgical Catgut

Biological evaluation/biocompatibility test report of medical device as per ISO standards (if applicable)

Risk management analysis as per ISO standard (if applicable)

Recently issued validation report for sterilization process for two commercial batches (if applicable)

Product Label (primary and secondary) Submit original label including following information

Name of product [Approved name and brand name (if any)]

Name and address of the actual manufacturer

Whether the product is sterile and mode of sterilization

Storage conditions specifying the temperature

Manufacturing date, Expiry date and Lot no/ batch no. (if applicable)

Patient information Leaflet

Product information leaflet for the products which are individually handled by the patient in the household should be in both Sinhala and Tamil languages
Eg : Glucometers, Hearing aids, spacer device etc.

Validity Period of registration

The Provisional Registration for a period of one year (or two) will be issued for first time registration and is specified in the certificate

The Full Registration of a product is valid for a period of five years and is specified in the certificate

When additional data are requested, the applicant will have to furnish additional information requested by the authority within 3 months to facilitate further evaluation

If the product is rejected, the market authorization holder will be able to appeal for registration

Renewal of Registration

Application for renewal should be made before six months from the date of expiry of registration

A grace period will extend until the decision is given to the application for renewal

If the requirements for registration are not satisfactory the application will be rejected completely

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