GMP Waiver for Listed and Class 1 Devices in Sri Lanka, 2025 to 2027

1. Key takeaways

The Sri Lankan NMRA has decided to waive the GMP inspection requirement for the production sites of Listed medical devices and Class 1 medical devices. Qualifying manufacturers may apply for product registration without first holding GMP approval, but they must submit the prescribed documents to the Medical Devices and Regulatory Division responsible for production, the MFRD, in exchange for a GMP Waiver Document, which is then submitted together with the product registration application in place of the GMP approval. At the same time, the NMRA has granted a blanket two-year GMP approval covering the period from 10 May 2025 to 9 May 2027; after 9 May 2027, only ISO 9001 will be accepted in place of a GMP inspection. Manufacturers should treat the waiver as a bridge arrangement with a fixed end date, not as a permanent relaxation.

• Waiver scope: production sites of Listed devices and Class 1 devices.
• Documents to submit: the Site Master File (SMF), together with business registration information, the site layout, a brief description of production activities, and the list of products to be manufactured.
• Submission timing: every Thursday, submitted to the MFRD.
• Document received: the MFRD issues the GMP Waiver Document, which is submitted with the product registration application and replaces the GMP approval.
• Blanket approval period: from 10 May 2025 to 9 May 2027 (two years).
• After the period: only ISO 9001 is accepted in place of a GMP inspection after 9 May 2027.
• Enquiries: the MFRD, and the CEO of the NMRA.

2. Legal basis

The waiver arrangement comes from the NMRA announcement addressed to local medical device manufacturers. The table below sets out the scope of the waiver, the documents and the weekly submission routine, the waiver document itself, the blanket approval period, and the rule that applies once the period ends.

3. Expert insights

Insight one: this is a double-deadline arrangement, and the two lines must be recorded separately. The first line is the blanket GMP approval, running from 10 May 2025 to 9 May 2027. The second line is the ISO 9001 transition window: the NMRA has given affected manufacturers two years to obtain ISO 9001, and after 9 May 2027, ISO 9001 becomes the only certificate that can replace a GMP inspection. A project that mixes the two lines in one plan risks reading the end of the blanket approval as the end of all options, when in fact the ISO 9001 route continues, provided the certificate is in hand by the cut-off.

Insight two: the waiver does not mean exemption from documents. Manufacturers must still submit the SMF and its supporting documents; what they avoid is passing the GMP approval stage first. Reading the waiver as if nothing had to be submitted is the most common misinterpretation of this policy. The MFRD still reviews the submitted material, and a thin or inconsistent SMF can delay the issue of the GMP Waiver Document just as a weak dossier delays a registration.

Insight three: this arrangement and the foreign-site international inspection exemption run in parallel. This article addresses local manufacturers with Listed or Class 1 sites; the exemption discussed under Article 16 addresses foreign sites already inspected by an SRA or the WHO. The beneficiaries differ and the two cannot be applied interchangeably. A project involving both local and foreign production must therefore run the correct scheme for each site rather than applying one template across all of them.

4. Practical recommendations

• Write both dates into the quality calendar: 10 May 2025, the start of the blanket approval, and 9 May 2027, the point after which ISO 9001 becomes the only accepted alternative.
• If the project cycle extends past May 2027, start preparing the quality system certificate well in advance, otherwise the available alternative route is lost after the deadline.
• Prepare the SMF and the supporting documents (business registration, site layout, production activity description, product list) as a complete pack before the Thursday submission.
• Track the issue of the GMP Waiver Document as a milestone in the registration plan, since the product registration application depends on it.
• For enquiries, address the MFRD first, with the CEO of the NMRA as the escalation point named in the announcement.
• Keep the local waiver scheme separate from the foreign-site SRA or WHO exemption in all project documents.

5. Verification checklist

• □ It has been confirmed whether the product is a Listed device or Class 1
• □ The Site Master File (SMF) has been compiled
• □ Submission to the MFRD has been made on a Thursday
• □ The GMP Waiver Document has been obtained
• □ The 9 May 2027 cut-off has been marked in the quality calendar
• □ The timing for obtaining ISO 9001 or ISO 13485 has been planned
• □ The blanket approval period of 10 May 2025 to 9 May 2027 has been checked against the project schedule

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.