Foreign Manufacturing Site Approval (FMSA) for Sri Lanka Medical Device Registration

1. Key takeaways

The Foreign Manufacturing Site Approval (FMSA) is the first gate on Sri Lanka’s full registration route. The FMSA section must contain: the FMSA application form, the commercial and company registration documents of the MAH, the manufacturer’s declaration of compliance, the declaration of the regulatory pharmacist or qualified person, the Site Master File (SMF, mandatory for all device FMSA applications), and the list of countries or regions to which the products are exported. The NMRA medical device page adds that site approval is applied for online through the eNMRA portal, that one application must be filed for each site separately, that document review (including the SMF) comes first, and that the GMP on-site inspection follows once the documents pass.

• The FMSA application form is the opening item of the FMSA section under GL-034, which took effect on 23 July 2025.
• The MAH’s commercial and company registration covers the local agent’s business licence, board of directors registration documents, and company registration certificate.
• The manufacturer’s declaration of compliance covers the production site, the agency authorisation, and the commitment to the authenticity of the documents.
• The professional declarations cover the local compliance responsible person’s letter and the declaration of the regulatory pharmacist or qualified person.
• The Site Master File is mandatory for all device FMSA applications, without exception.
• The list of export countries or regions must be included in the dossier.
• Site approval is submitted online through the eNMRA portal, with one application per site.
• The review sequence is document review (including the SMF) followed, once the documents qualify, by the GMP on-site inspection.

2. Legal basis

The requirements for the FMSA section come from GL-034, effective 23 July 2025, and the procedural description of online filing and review comes from the NMRA medical device page. The table below lists each required element and its source. Reading it as a checklist rather than as background matters here, because the acceptance of the FMSA section depends on every listed element being present.

3. Expert insights

Insight one: the SMF is a mandatory item, with no room for exceptions. The wording of GL-034 is that the SMF is mandatory for all device FMSA applications. If this one item is missing, the entire FMSA stage cannot advance. Manufacturers sometimes assume that an established site with an existing quality system can shorten or skip the SMF, but the rule leaves no such discretion, and the SMF should therefore be prepared to the expected standard before the application is even drafted.

Insight two: the relationship between site approval and product registration is one-to-many in one direction and one-to-one in the other. A single FMSA can support multiple PRDs, covering several products from the same foreign site, but every site must file its own separate application. Multi-site manufacturers need to plan the number of applications and the budget according to the number of sites. Treating the group as one regulatory entity rather than several sites is a common planning error that surfaces late, when fee schedules and timelines have already been communicated to management.

Insight three: document review comes first and the on-site inspection follows. This sequence means that the quality of the documents determines whether an on-site inspection is triggered at all. A site whose documents do not pass will not even reach the stage where an inspection is scheduled. The practical reading is that investment in a clean, complete and internally consistent FMSA package is the cheapest form of inspection avoidance available under the Sri Lankan process.

4. Practical recommendations

• For multi-site clients, first draw up a site map: list every production site involved, the product range each site covers, and the status of each site’s quality certificates.
• Then work backwards from the rule of one application per site to derive the number of applications and the budget required.
• Confirm in parallel which sites may qualify for the GMP exemption conditions (see the dedicated article on the SRA and WHO exemption, Article 16).
• Start the SMF early for every site, since it is mandatory for all device FMSA applications and cannot be waived.
• Collect the MAH commercial and company registration documents and both sets of professional declarations alongside the SMF, so the full FMSA section matures together.
• File each site’s application through the eNMRA portal separately and track the document review outcome per site before planning inspection readiness work.

5. Verification checklist

• □ All foreign production sites involved have been listed
• □ An independent FMSA application form has been prepared for each site
• □ The Site Master File (SMF) has been compiled
• □ The MAH’s commercial and company registration documents are ready
• □ The manufacturer’s declaration of compliance and the professional declarations have been obtained
• □ The list of export countries or regions has been compiled
• □ The site application has been submitted through the eNMRA portal
• □ The document review outcome for each site has been recorded before inspection planning begins

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Sri Lanka. Our team prepares dossiers to NMRA expectations, manages submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of 28 October 2026.