Medical Device Regulation Under the NMRA Act No. 5 of 2015
The National Medicines Regulatory Authority (NMRA) of Sri Lanka regulates medical devices under the NMRA Act No. 5 of 2015 and subsidiary regulations. The NMRA is responsible for the registration, quality assurance, and post-market surveillance of medical devices imported or manufactured in Sri Lanka.
Key requirements:
- Device Registration: Medical devices must be registered with the NMRA before importation or sale. The registration dossier includes technical documentation, labelling, and evidence of marketing authorisation in the country of manufacture or a recognised reference market.
- Risk-based approach: The NMRA applies a risk-based classification approach broadly aligned with the IMDRF/GHTF framework.
- Local Authorised Representative: A Sri Lanka-based entity is required to hold the NMRA registration on behalf of foreign manufacturers.
- GMP/Quality System evidence: Manufacturers must provide evidence of GMP compliance, typically a Free Sale Certificate or GMP certificate from the country of origin.
📅 Effective / published: NMRA Act — 2015; regulations updated periodically
Sri Lanka's regulatory capacity is developing, and submission timelines can vary. Foreign manufacturers should work with a reputable local regulatory consultant or authorised representative familiar with current NMRA requirements and processing norms. Ensure your device holds valid marketing authorisation in its home market, as this is a key reference document for NMRA review.
View official source (NMRA Sri Lanka) ↗