Sri Lanka Medical Device Regulator: NMRA Authority Overview

1. Key takeaways

The regulatory authority for medical devices in Sri Lanka is the National Medicines Regulatory Authority (NMRA), which operates under the Ministry of Health. Under the National Medicines Regulatory Authority Act, 2015 (Act No. 5 of 2015), NMRA is responsible for the registration, licensing, manufacture, import, and the regulation and control of all related aspects of medical devices, and it must exercise this mandate in a manner consistent with the national medicines policy. NMRA was established in March 2015 and has been operational since 1 July 2015. For any manufacturer planning market entry, this means that a single national authority sits at the centre of every device decision, from dossier preparation through import control and post-market oversight, and that all project planning should be built around NMRA procedures rather than around several parallel agencies.

• NMRA is the national regulator for medical devices in Sri Lanka and operates under the Ministry of Health.
• The governing statute is Act No. 5 of 2015, certified on 19 March 2015 and operational from 1 July 2015.
• NMRA authority covers registration, licensing, manufacture, import and all related aspects of devices.
• The former Cosmetics, Devices and Drugs Act No. 27 of 1980 has been repealed by Act No. 5 of 2015.
• Pricing and advertising compliance fall within the authority’s remit and must be planned alongside registration.

2. Legal basis

The table below consolidates the legal sources that establish NMRA, define the date on which it began to operate, and enumerate the scope of its powers over medical devices. Each row corresponds to a matter that should be verified against the primary source before it is cited in a regulatory submission or in any contractual document.

3. Expert insights

Insight 1: NMRA is the “only” regulator, not one authority among several. The wording used in the official annual report is that NMRA is the single government body in Sri Lanka responsible for regulating all categories of medicines, medical devices and borderline products. This is materially different from the layered structures seen elsewhere in the region, such as India, where CDSCO operates at the centre alongside state-level authorities, or the Philippines, where the central FDA coexists with local government units. In practice, this means that device market approval in Sri Lanka is more centralised: there is no second administrative layer whose interpretation must be anticipated, and no provincial variant of the same requirement. The practical consequence is that a well-prepared submission faces one audience only, and that the quality of the interaction with that single audience determines the outcome of the project.

Insight 2: the scope of the authority’s powers is drafted very broadly. The objectives clause of Act No. 5 of 2015 enumerates a full chain of functions, running from registration and licensing through pricing, storage, transport, advertising and disposal. The implication is that pricing compliance and advertising compliance fall within the NMRA remit just as much as registration does. A company that builds a market plan around the registration step alone has not discharged its regulatory obligations: the promotional material it publishes and the price at which it places the product on the market are both matters on which the authority has been given express statutory functions. Marketing planning must therefore treat these two areas as regulatory workstreams in their own right, with the same level of documentation and internal review as the dossier itself, rather than as commercial matters that sit outside the regulatory perimeter.

Insight 3: the legal history contains a clearly identifiable “track switch” point. Before 1 July 2015, the framework was provided by the CDD Act No. 27 of 1980 together with the regulations of 1984; from that date onward, the framework is provided by Act No. 5 of 2015, which replaced the earlier regime. This matters for historical documents: citing a provision of the old law as the basis for a current compliance judgement is an outdated basis. Certificates, approvals and internal procedures drafted under the previous regime should be re-expressed in terms of the current statute before they are relied upon, and any legacy reference to the 1980 law or the 1984 regulations should be treated as a signal that the document needs to be reviewed and updated.

4. Practical recommendations

• At the start of any Sri Lanka project, prepare a mapping table that links each authority, division and process step, so that every action in the project has a clearly identified counterpart inside NMRA.
• Map the Medical Device Regulatory Division to reception and review of dossiers, since this is the division that handles the submission itself.
• Map the Market Control Division to import, market inspections, advertising, recalls and GDP checks, so that post-approval obligations are routed to the correct contact point.
• Map NMQAL to laboratory testing and map MDEC to technical evaluation, so that sample testing questions and technical assessment questions are directed separately and do not delay each other.
• Use the completed table to answer directly who should be approached at each step, which prevents the registration, import and advertising workstreams from being pushed forward as a single undifferentiated effort.

5. Verification checklist

• □ It has been confirmed that the competent authority is NMRA, under the Ministry of Health.
• □ It has been confirmed that the current parent law is Act No. 5 of 2015, and not the CDD Act No. 27 of 1980.
• □ The relevant NMRA internal divisions have been identified (Medical Device Regulatory Division / Market Control Division / NMQAL).
• □ It has been confirmed that MDEC is the technical evaluation body and that it meets monthly.
• □ Pricing and advertising compliance have been brought within the scope of the project.

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