Maven
Medical-Devices-Registration-in-Sri-Lanka

Medical Devices Registration in Sri Lanka

Contact Us

Are You Looking For Medical Devices Certifications?

Click Now!

Connect With Us

    MDR-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.

    MDR

    Registration Fees

    Processing Fee

    Processing-Fee

    Fees For Additional Data Evaluation

    Fees-for-Additional-Data-Evaluation

    Fees For License

    Fees-for-License

    Required Documents for Medical Devices Registration in Sri Lanka

    • Request letter for registration: A formal request letter addressed to the regulatory authority.
    • Business registration certificate: Proof of the manufacturer’s legal entity in their home country.
    • Authorization Letter: Authorizing a local representative or agent to act on behalf of the manufacturer.
    • Free Sales Certificate: Confirming that the medical device is freely sold in the manufacturer’s home country.
    • Sample license: License permitting the importation of sample devices for registration purposes.
    • Certificate from the manufacturing country: Attesting to the device’s compliance with regulatory standards in the manufacturing country.
    • List of countries with prior approval: Details of countries where the device has already been approved for sale.
    • Registration Dossier: Comprehensive documentation outlining the device’s specifications, safety, and performance.
    • Product samples: Actual samples of the medical device for evaluation purposes.
    • Labels, IFUs: Labeling and Instructions for Use (IFUs) in compliance with Sri Lankan regulations.
    • Test Reports, Clinical Studies Reports: Reports demonstrating the device’s safety and efficacy through testing and clinical studies.
    • QMS certificate: Certificate confirming adherence to Quality Management System (QMS) standards.
    • CE certificate: Certificate indicating compliance with European Union (EU) regulations, if applicable.

    Ensuring all necessary documents are prepared and submitted accurately is essential for a smooth and successful registration process for medical devices in Sri Lanka.

    License Validity

    LICENSE TYPE VALIDITY PERIOD
    Provisional Registration 1 or 2 Years
    Full Registration 5 Years
    Import License 1 Year

    Ensure compliance with Sri Lanka’s regulations by obtaining the appropriate medical devices registration licenses. The validity periods vary depending on the type of license, ranging from 1 to 5 years.

    Special Requirements

    • Chemical, Physical, and Biological Properties: Medical devices must meet stringent standards regarding their chemical, physical, and biological properties to safeguard patient health.
    • Infection Risk Minimization: Measures should be in place to minimize the risk of infection and microbial contamination to patients, users, and other individuals.
    • Safety in Construction and Environment: Devices must demonstrate safe construction and environmental properties to mitigate potential hazards.
    • Measurement Accuracy: Medical devices with measuring functions should deliver precise and stable measurements to ensure reliable performance.
    • Radiation Protection: Adequate protection against radiation is essential to safeguarding the health and safety of patients, users, and others.
    • Energy Source Reliability: Devices connected to or equipped with energy sources must be designed and produced to ensure optimal performance, reliability, and repeatability while minimizing risks associated with potential faults.

    Compliance with these special requirements is critical for manufacturers seeking medical device registration in Sri Lanka. By prioritizing safety and quality in device design and production, companies can ensure regulatory compliance and enhance confidence in their products within the Sri Lankan market.

    Entrust your medical devices registration process in Sri Lanka to Maven, where expertise meets efficiency. With our comprehensive services, navigating the intricacies of medical devices registration becomes seamless. Benefit from our tailored solutions designed to ensure compliance with regulatory standards in Sri Lanka, allowing you to focus on your core business objectives. Partner with Maven for a smooth and successful registration process, ensuring your medical devices gain market access and meet all requirements in Sri Lanka.

    Our Blogs

    LATEST NEWS

    Blog Image

    May 16th, 2024

    Navigating Regulatory Challenges For Drug-Device Combination Products in EU

    Read More
    Blog Image

    May 8th, 2024

    SOUP In Medical Devices

    Read More
    Blog Image

    April 29th, 2024

    Medical Device Regulation for Custom-made Devices

    Read More

    Connect With Us

      mail
      ×