Reference Regulatory Authorities Recognised by Sri Lanka NMRA for the Reliance Pathway

1. Key takeaways

The reference countries and regions recognised by Sri Lanka for the reliance pathway are, for general medical devices: the United States, the United Kingdom, Australia, Canada, Japan, Norway, Switzerland and all European Union member states. For IVD in vitro diagnostic devices, Singapore is added on top of that list. When a reference-country approval is used as the basis for reliance, two conditions must both be satisfied: the approval must be within its period of validity, and the model and technical specifications of the product must exactly match the product being submitted. These two conditions work as a pair, and failing either one removes the eligibility that the approval would otherwise provide.

• For general devices, the recognised reference jurisdictions are the United States, the United Kingdom, Australia, Canada, Japan, Norway, Switzerland and all European Union member states.
• For IVDs, the same list applies with Singapore added.
• Recognised approval types include FDA 510(k) or PMA, EU CE marking under MDR 2017/745 or IVDR 2017/746, UK UKCA, Australian ARTG, Japanese PMDA/MHLW approvals, and Canadian MDL.
• The reference approval must be within its period of validity and in normal status.
• The model and technical specifications of the submitted product must exactly match those of the reference-approved product.
• Qualifying reliance can exempt the applicant from sample import and the performance evaluation.

2. Legal basis

The list of recognised jurisdictions and the conditions attached to reliance are compiled from the NMRA reliance pathway information. The table below sets out the scope, the recognised approval types, and the validity and consistency requirements that an application must satisfy.

3. Expert insights

Insight one: the list is organised by country or region, not by certificate. What the NMRA lists are the jurisdictions of the regulatory authorities, not any specific certificate. The practical consequence is that the issuing body must first be located within a listed jurisdiction, and only then should the certificate type be confirmed. A certificate from a notified body, for example, must be traced back to the member state that designated it before the EU entry on the list can be relied upon. Applicants who skip this step sometimes present certificates whose issuing authority sits outside the recognised scope, and the reliance basis collapses at review.

Insight two: adding Singapore separately for IVDs shows that IVDs and general devices are treated as two independent tracks. This is consistent with the logic of the Sri Lankan dual-track classification system. IVDs form a self-contained set across classification, reference jurisdictions and product-specific evidence in the form of the performance evaluation report. A mixed portfolio manufacturer therefore cannot assume that a single reference-approval strategy serves both device families, and the IVD track must be mapped on its own terms.

Insight three: the exact-match standard is a hard standard. Even differences that look minor, such as packaging or colour, can cause the reliance to fail. This point deserves special attention when preparing the label and accessory lists. The comparison must be made at the level of what the reviewer will actually see: the labelled model designation, the technical specification sheet, and every accessory claimed in the submission.

4. Practical recommendations

• Build a reference-approval evidence pack for the client file containing a copy of each certificate, the information of the issuing authority, proof of the validity period, and an item-by-item comparison table of the models and specifications of the submitted product against the reference-approved product.
• Have the comparison table signed and confirmed by the manufacturer, because at review this is a document that can be accepted directly and is far more effective than an oral explanation.
• Trace every certificate back to the jurisdiction of its issuing body before checking the certificate type against the recognised list.
• Check the validity status of each approval close to the filing date, not only when the project starts.
• Extend the comparison to packaging, colour and accessories, since the exact-match standard reaches those details as well.
• For IVDs, run the mapping twice: once against the general-device list and once with Singapore added, so the IVD track is assessed on its own terms.
• Update the evidence pack whenever a certificate is renewed, superseded or amended, because a stale pack is a common source of review queries.

5. Verification checklist

Run the checks below before the route decision is finalised, and repeat them if any certificate changes before filing.

• □ The jurisdiction of the issuing body has been confirmed as being on the list
• □ The certificate type has been checked (510(k), PMA, CE, UKCA, ARTG, MDL)
• □ The validity period of the certificate has been checked
• □ The model and specification comparison table between the submitted product and the reference product has been prepared
• □ The comparison table has been signed and confirmed by the manufacturer
• □ Packaging, colour and accessory differences have been reviewed against the exact-match standard
• □ The evidence pack is complete and stored where the submission team can retrieve it quickly

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.