Overview on Medical Device Registration in Sri Lanka

Regulatory Authority

National Medicines Regulatory Authority (NMRA)

The National Medicines Regulatory Authority (NMRA) is an independent authority in the Ministry of Health established in 2015, ensuring that medicinal products meet safety, quality, and efficacy standards. It regulates medicines, medical devices, borderline products, clinical trials, and cosmetics.

The NMRA is governed by a board, which provides strategic leadership and advises on the authority’s functioning. The board does not have any involvement in regulatory decision-making, but the chief executive works with regulatory staff and expert advisory committees.

The primary objective is to increase patient access to quality-assured medicinal products. The NMRA has a code of conduct to ensure integrity, impartiality, and independence. Their work includes assessing medicinal product needs, registering, and licensing medicines, providing guidance on classification, regulating prices, regulating pharmacies, recommending amendments, educating the public, supporting post-marketing surveillance, and regulating clinical trials.

Link for Regulatory Authority

https://nmra.gov.lk/index.php?lang=en

Local Regulation

THE NATIONAL MEDICINES REGULATORY AUTHORITY ACT, No. 5 OF 2015

https://nmra.gov.lk/index.php?option=com_content&view=article&id=366:register-your-product&catid=36&Itemid=305&lang=en

Classification of Medical Devices

Class I, IIa, IIb and III

Listing or Registration Requirements

The device registration and import into Sri Lanka is a three-step process:

• Obtain Sample Import License
• Device Registration and Approval by the NMRA
• Import License

Sample Import License

The process demands the need to operate the device under sample license after which the manufacturer must again approach the NMRA for final approval, which again involves procuring multiple certifications.

Device Registration

The application for device approval along with a copy of sample Import License and samples for testing must be submitted to the NMRA. The agency also requires sample labels and Instructions for Use (IFU) in two locally recognized languages along with English and must be contextually aligned with original label which pose translation challenges.”

Documents Required for Sri Lanka Medical Device Registration

• Obtaining Sample Import License by submitting
  • a copy of business registration certificate of the applicant [should indicate the board of directors, Secretarial board (BR 1)]
  • letter of authorization from the manufacturer appointing the local agent

1. Schedule I, Form A & Form B
2. Copy of sample import license
3. Free sale certificate
4. Fully packed samples (two) of devices in the form that is intended to be marketed
5. List of countries which the device is approved or registered for sale with copies of registration certificates
6. Label/ catalogue/ User Manual
7. Patient Information Leaflet

Technical Specifications

1. Final Product Inspection Report

Electro medical equipment and machines: Submit the manufacturer’s or third-party laboratory’s batch release report.
Other products: Submit finished product test reports.

2. Test Reports for Specific Items

Independent analytical certificates for products in direct contact with the bloodstream (e.g., syringes, needles).
Analytical test reports from accredited laboratories for various products, following pharmacopeia standards where available.

3. Material Test Reports

Provide material test reports for items like sutures, medical instruments forceps, scissors).

4. Quality Management Certification

Obtain ISO 13485 certification from an authorized notified body for design, development, manufacturing, and post-marketing monitoring.

5. CE Accreditation

Obtain CE accreditation from an authorized notified body, along with an EC design examination certificate if applicable.

6. Stability Data

Provide stability data for the entire shelf life of finished products if applicable.

7. Additional Requirements for Absorbable Sutures
   • Keep absorbable suture samples at NMRA for six months before evaluation.
   • Provide details of raw material sources and purchasing.
   • Obtain relevant authorities’ approval certificates, as necessary.
8. Radiation Emitting Devices

Obtain approval from the Atomic Energy Authority of Sri Lanka for radiation emitting devices.

9. BSE Certification

For animal-derived products like Surgical Catgut, obtain certification from the relevant health authority that the product is free from BSE.

10. Biological Evaluation and Risk Management

Provide biological evaluation/biocompatibility test reports per ISO standards if applicable.
Include risk management analysis as per ISO standards if applicable.

11. Validation Report for Sterilization Process

Provide a recently issued validation report for the sterilization process for two commercial batches if applicable.

Registration Timeline

New full product registration will take a minimum of 6 months

Registration Fee

New product registration-

• Processing fees: USD 1000
• Application for Registration Renewal (after 5 years) – USD 500
• Additional data evaluation: USD 500
• Certificate registration issuance: USD 400
• Sample import license: USD 100
• Import license: USD 100

License Validity

• Provisional registration certificate – 1 or 2 years
• Full registration certificate – 5 years
• Import license – 1 year

License Renewal

Application for renewal should be made 6 months before the date of expiry of registration. A grace period will extend until the decision is given to the application for renewal.
Import licenses should be renewed every year.

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

Special Labelling Requirements

Additional Comments

Each new product will always be granted a 1-year provisional registration certificate. This certificate will be valid for 1 or 2 years. NMRA will mention if they require any additional information/documentation. After furnishing all additional requests to the authority, the full registration certificate with a longer expiration date will be granted.

Recall of Medical Device

• NMRA may recall any medicine, medical device, or borderline product
  • on a report or certificate issued by an additional approved analyst or by the approved analyst as specified in the Act.
  • on the recommendation of the Medicines Evaluation Committee (MEC), Medical Devices Evaluation Committee (MDEC) or the Borderline Products Evaluation Committee (BPEC)
  • on the recommendation of the Safety of Medicines and Risk Evaluation Sub Committee\
  • on safety alerts issued by the World Health Organization or any other National Regulatory Agency
• The marketing authorization holder for any medicine, medical device, or borderline product shall voluntarily recall a product if any evidence appears casting doubts on its quality, efficacy, or safety. The marketing authorization holder shall inform the Authority within 24 hours of initiating such voluntary recall.

Classification of Recall

https://nmra.gov.lk/images/PDF/guideline/Guideline-on-Recall.pdf

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk