Medical Devices Registration in Sri Lanka

Medical Devices Registration Process

• Device Classification: Begin by determining the classification of your medical device according to Sri Lankan regulations.
• Authorized Representative Appointment: Appoint an authorized representative in Sri Lanka to facilitate the registration process on your behalf. All foreign medical device manufactures should submit application for registration through a Marketing Authorization Holder (local agent) in Sri Lanka who shall be responsible for the registration, licensing, importation, sale and distribution, handing of quality failures and all aspects pertaining to the particular medical device in Sri Lanka.
• Administrative Documentation: Prepare the necessary administrative documentation addressed to the Director of the Cosmetics, Devices, and Drugs Authority (CDDA). Apply for a sample license, and upon payment of fees, the application will be processed and entered into the official register.
• Sample License Issuance: Upon approval, three copies of the sample license will be issued, each valid for one year.
• Registration Dossier Preparation: Assemble the registration dossier containing all required documentation.
• Submission and Review: Your local agent will submit the dossier along with product samples to the relevant authorities for review.
• Registration Certificate Issuance: Upon approval, the registration certificate will be granted, allowing for the importation and distribution of the medical device in Sri Lanka.
• Import License Application: With the registration certificate in hand, the manufacturer can proceed to apply for an import license to legally import the medical device into Sri Lanka.
• Approval of Foreign Manufacturing Facilities:
  • This process pertains to foreign manufacturers of pharmaceuticals and medical devices seeking marketing authorization for their products in Sri Lanka. It involves reviewing essential documents, including the site master file, and may require a Good Manufacturing Practice (GMP) inspection of the facility before approval.
  • Foreign manufacturers aiming to register products in Sri Lanka must designate a local authorized agent within the country. This agent will submit an application for approval of the overseas manufacturer on behalf of the foreign company. Separate applications are necessary for each manufacturing site intending to export products to Sri Lanka, with a processing fee applicable for each application based on NMRA fee regulations.
  • Once the manufacturer meets all requirements outlined in the application, including submitted documents, the next step involves a GMP inspection of the facility. The NMRA may waive the onsite GMP inspection if the site has been inspected by a recognized National Regulatory Authority (NRA) or the World Health Organization (WHO), as per Regulation 24 of the Medicines Regulations. Following these procedures, an approved foreign manufacturer can apply for marketing authorization for individual products through their local agent.
• Site Master File(SMF): A Site Master File comprises documents necessary to accompany applications for site approval. It furnishes the NMRA with an overview of the manufacturing site, covering premises, personnel, processes, documentation, and equipment used in manufacturing, processing, packaging, quality control, storage, distribution, complaint handling, and recall procedures for medicines, medical devices, borderline products, and cosmetics.

By following these steps diligently, you can ensure the smooth registration and importation of your medical devices in Sri Lanka, complying with all necessary regulations and requirements.

Registration Fees

Processing Fee

Fees For Additional Data Evaluation

Fees For License

License Validity