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With the growing economy and population, the demand for safe and effective healthcare facilities has increased in Sri Lanka. National Medicines Regulatory Authority (NMRA) of Sri Lanka is responsible for assuring that the medical devices imported into Sri Lanka pertain to high standards of safety, quality and efficacy. For the same reason, NMRA has efficiently crafted the Regulatory approval process with the most critical component - the manufacturing site registration.
All the local and foreign medical device manufacturers who wish to place medical devices in Sri Lanka must register their manufacturing sites as a preliminary step. All the applicants need to fill an application via the e-NMRA process with the following details:
- Foreign manufacturers must appoint a registered local agent and submit the reference number of the local agent.
- All the applicants must submit a legal manufacturer name (as in FSC/CE/ISO) and manufacturing site details. Multiple manufacturing sites located in different countries require separate applications. The manufacturer must include the location of the site, whether the site is owned by the manufacturer or is a contract manufacturing site.
- Applicants must select the fields based on the details applicable for the device in scope.
- The list of supporting documents to be submitted are:
- Authorization letter issued to the local agent. In the case of multiple local agents, the information of products and manufacturing sites for each local agent must be submitted.
- Product list (separate product list for every manufacturing site)
- A valid manufacturing license, where necessary, must be submitted
- List of exporting countries (on legal manufacturer’s letterhead)
- A valid GMP certificate (where available), FSC, hygienic certificate (sanitary products)
- Certificate issued by the chamber of commerce (optional)
- ISO certificate or a justification statement for its unavailability
- Details of other manufacturing sites (name of the manufacturing site and its location)
- Declaration letter for the status of the manufacturer (either own site or CMO site), site readiness for NMRA inspection, the authenticity of SMF and/or other documents, the authenticity of information submitted in the application (by Regulatory pharmacist/ qualified person, as per the format available on the NMRA website)
- Site Master File (SMF) - Separate files for each manufacturing site must be submitted. The SMF must include the details of manufacturing site, list of products manufactured in the site, legal manufacturer, other manufacturing sites owned by the manufacturers, annual turnover of the company for the last three (03) years, list of exporting countries with evidence from two (02) countries. The QMS documentation must include details of facility and equipment; design, manufacture, packaging, sterilization operations, personnel information; quality control and assurance process; self-inspection, audit, vendor qualification, complaint handling and product recall procedures, etc.
After successful submission and assessment of all the documents, NMRA carries out mandatory onsite GMP inspection before approving the manufacturing site. The main complication can arise during the submission of documents at the desk review by the NMRA, as the requirement is very specific and requires utmost attention. NMRA has set definite guidelines, which are needed to be followed by the manufacturers for getting approval for their manufacturing sites to place their devices in the Sri Lankan market. To avoid procedural setbacks during the manufacturing site registration, reach out to a Regulatory expert. Stay informed.
