GMP Inspection Exemption for Sites Inspected by SRAs or the WHO in Sri Lanka

1. Key takeaways

The Sri Lankan NMRA has indicated that where a manufacturing site has already been inspected by a stringent regulatory authority (SRA) or by the World Health Organization (WHO), the NMRA will waive its GMP on-site inspection. Whether the exemption applies is decided by the NMRA on a case-by-case basis. This exemption interlocks with the reference-approval logic of the reliance pathway, and the two together form Sri Lanka’s system of relying on international evidence. Applicants should read the exemption as an option that must be evidenced and requested, not as an automatic right that follows from the mere existence of a past inspection. Because the decision sits with the NMRA, the strongest application is one that lets the reviewer reach a positive answer without asking a single follow-up question.

• Exemption condition: the site has already been inspected by a stringent regulatory authority or by the WHO.
• What is exempted: the GMP on-site inspection.
• Who decides: the NMRA determines whether the exemption applies.
• Normal route: document review (including the SMF) followed, once qualified, by the GMP on-site inspection.
• Quality certificate baseline: the NMRA generally expects ISO 13485; ISO 9001:2015 is accepted only in limited situations (practical estimate).
• FMSA within the consolidated dossier: merged with the PRD into a single submission under GL-034.

2. Legal basis

The exemption is described on the NMRA medical device page, and its position within the consolidated dossier follows GL-034. The table below separates the exemption itself from the normal review route and from the quality certificate baseline that sits behind it. Reading the rows in order matters, because the exemption only modifies the last step of the normal route; everything before it, including the SMF and the document review, still applies in full.

The quality certificate baseline deserves a separate note. The expectation of ISO 13485 as the general baseline, with ISO 9001:2015 accepted only in limited situations, is a practical estimate drawn from NMRA practice rather than a fixed rule quoted from a guideline, so it should be confirmed against the current NMRA position at the time of filing.

3. Expert insights

Insight one: what is exempted is the on-site inspection, not the site approval. The FMSA as a stage still exists; only the physical visit to the factory is waived. Manufacturers should therefore keep the site approval fee in the budget even when the exemption is expected to apply. The exemption shortens the calendar and removes inspection readiness work, but it does not remove the site-level application, the document review or the SMF obligation that come before it.

Insight two: whether the exemption applies is determined by the NMRA, not claimed by the applicant. This means that the sufficiency of the evidence determines the outcome. The application should provide verifiable information about the inspection: the inspection report, the identity of the inspecting authority, the date of the inspection and its scope. A bare assertion that the site has been inspected before, without documents that the NMRA can check, gives the reviewer nothing to base a waiver decision on and invites a deficiency request instead.

Insight three: this exemption and the local GMP inspection waiver order are two different things. This article covers the exemption of a foreign site on the basis of an international inspection; the separate arrangement covered elsewhere concerns the waiver order for local Listed and Class 1 device production sites (see Article 17). The legal basis, the beneficiaries and the application procedure differ, so the two schemes cannot be substituted for each other, and an applicant qualifying under one should not assume anything about the other. Keeping the two schemes separate in the project documentation also prevents an incorrect waiver reference from reaching the dossier and raising questions at review.

4. Practical recommendations

• First confirm whether the production site has been inspected by a stringent regulatory authority or by the WHO.
• Obtain and organise the inspection evidence: the report, the inspecting authority, the date and the scope of the inspection.
• Raise the exemption request explicitly in the FMSA section, with the evidence attached, rather than expecting the NMRA to notice it.
• Reserve time in the plan for being asked to supplement documents or to accept an inspection anyway.
• Keep the expectation written as a scenario rather than a promise, so that either outcome, waiver or inspection, fits the schedule without renegotiation.
• Distinguish clearly in the project file between this foreign-site exemption and the local waiver order, so the correct procedure is used for each site.

5. Verification checklist

• □ It has been confirmed whether the production site has been inspected by an SRA or the WHO
• □ Verifiable evidence such as the inspection report has been obtained
• □ The exemption request has been raised in the FMSA section with the evidence attached
• □ Time has been reserved for a request to supplement documents or to accept an inspection
• □ The applicability of the foreign-site exemption versus the local waiver order has been distinguished
• □ The site approval fee remains in the budget even if the inspection is waived
• □ The evidence list covers the report, the inspecting authority, the date and the scope of the inspection

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.