Sri Lanka NMRA Act No. 5 of 2015: The Parent Law

1. Key takeaways

The current parent law for medical devices in Sri Lanka is the National Medicines Regulatory Authority Act, No. 5 of 2015, which was certified on 19 March 2015 and entered into operation on 1 July 2015. The Act expressly repeals the Cosmetics, Devices and Drugs Act, No. 27 of 1980 (CDD Act No. 27 of 1980) and the body of regulations made under it in 1984. The consequence for compliance work is direct and unavoidable: any document that cites the 1980 law or the 1984 regulations as its present legal basis is relying on an outdated basis. Every regulatory submission, authorisation letter, internal procedure and marketing claim in Sri Lanka should be anchored to Act No. 5 of 2015 and to the guidance issued under it, because the authority reviewing the file will assess it against the current statute and not against the repealed one.

• Act No. 5 of 2015 is the parent law for medical devices in Sri Lanka.
• The Act was certified on 19 March 2015 and became operational on 1 July 2015.
• The CDD Act No. 27 of 1980 and its 1984 regulations have been repealed.
• References to the repealed law as a current compliance basis are outdated.
• Devices are governed by a dedicated chapter of the Act, Chapter IV.

2. Legal basis

The table below sets out the key legal facts about Act No. 5 of 2015: its full name and certification date, the date from which NMRA operates under it, the express repeal of the former law, the institutional character of the authority, and the provisions of the Act that carry the device-specific and central regulatory functions. Each of these points can be traced to the statute itself, the NMRA website or the parliamentary annual report.

3. Expert insights

Insight 1: the transition point between the old law and the new law is 1 July 2015, not 19 March 2015. The Act was certified on 19 March, but NMRA only began to operate formally on 1 July. When assessing which legal basis governs a historical approval, certificate or registration decision, 1 July 2015 should be used as the dividing line. A document issued before that date sits under the repealed 1980 regime, while a document issued from that date onward sits under Act No. 5 of 2015. Mixing the two regimes in a single compliance argument creates confusion that reviewers will notice, and it is easily avoided by checking the issue date of every historical document against this boundary before it is cited.

Insight 2: in the structure of the law, devices have their own dedicated chapter. Chapter IV of Act No. 5 of 2015 is devoted to “controlling and regulating all aspects of medical devices”, and Chapter VI deals with sale, manufacture, import and pricing. This structure establishes that devices are not an appendix to medicines but a parallel object of regulation. That point is important for understanding the review logic in Sri Lanka: the authority assesses device dossiers under device-specific provisions, with their own chapter and their own functional coverage, rather than forcing device questions into a medicinal framework. Dossier preparation, terminology and internal quality procedures should reflect this parallel structure instead of borrowing language developed for medicinal products.

Insight 3: the “independence” of NMRA has boundaries. Official descriptions emphasise that NMRA is an independent authority that takes its own decisions; at the same time, they make clear that it is established under the Ministry of Health and is a semi-autonomous body. Understanding this boundary helps in judging which matters the authority decides on its own authority and which matters require coordination upward. In practical terms, a sponsor should treat NMRA as the decision-making body for registration and related questions, while recognising that policy-level positioning and institutional reporting sit with the Ministry. Correspondence and escalation strategies should be designed with this two-level reality in mind rather than assuming either full separation or full subordination.

4. Practical recommendations

• Update every outward-facing document so that the legal basis is stated uniformly as “under Act No. 5 of 2015 and the guidance issued under it”, including authorisation letters, dossiers, procedural documents and marketing materials.
• Retain in the internal archive a short legal-history note explaining the transition from the CDD Act No. 27 of 1980 and the 1984 regulations to Act No. 5 of 2015, so that reviewers of the file understand why legacy documents were superseded.
• Sweep all legacy templates for references to the 1980 law or the 1984 regulations and replace them before submission, since companies that reuse old templates are frequently asked during deficiency responses to re-explain the source of their legal basis, which costs an additional review cycle for no technical benefit.
• Where a historical document issued before 1 July 2015 is still relevant, restate its effect in terms of the current statute rather than citing the repealed provision directly.

5. Verification checklist

• □ The legal basis stated in all outward-facing documents has been updated to Act No. 5 of 2015.
• □ It has been confirmed that 2015-07-01 is the starting point of NMRA operations.
• □ Statements citing the CDD Act No. 27 of 1980 have been removed from current documents.
• □ The legal history has been recorded in the internal archive.
• □ It has been confirmed that devices are subject to the provisions of Chapter IV.

Regulatory information verified as of 28 October 2026.

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