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Sri Lanka Medical Device Regulation

Regulatory authority: National Medicines Regulatory Authority (NMRA) | Legislation: NMRA Act No. 5 of 2015 | Last reviewed: May 2026 | For reference only — not legal advice.

Sri Lanka regulates medical devices through the National Medicines Regulatory Authority (NMRA), an independent statutory body under the Ministry of Health established by the NMRA Act No. 5 of 2015. Sri Lanka's framework is distinctive in requiring two separate regulatory steps before commercial supply: first a Registration Certificate, then a separate Import Licence. All foreign manufacturers must appoint a Sri Lanka-based Marketing Authorization Holder (MAH) who carries full regulatory accountability.

Regulatory Pathway Map​

Click a phase to expand — each card links to the relevant section of this guide.

Getting Started
What is a Medical Device?
NMRA definition under the National Medicines Regulatory Authority Act — scope and key terms.
Read definition →
Getting Started
Regulatory Framework
NMRA structure, the two-step market entry process, and applicable Sri Lankan law.
View framework →
Getting StartedKey step
Who Must Comply?
Obligations for MAHs, importers, and local representatives under NMRA rules.
Check obligations →

Key Facts​

Regulatory bodyNMRA, Ministry of Health
LegislationNMRA Act No. 5 of 2015
ClassificationGeneral: Listed / Class I / IIa / IIb / III (EU-derived) · IVD: Class A / B / C / D
Two-step entryStep 1: Registration Certificate → Step 2: Import Licence
MAH requiredYes — Sri Lanka-based MAH holds all registrations
Foreign facilityMandatory NMRA site registration before product application
Reliance pathwayYes — from October 2025 (US · UK · AU · CA · JP · EU · SG · NO · CH)
Min. timeline6 months (full) · Shorter via reliance for Class I/IIa/IIb
AdvertisingPrior written NMRA approval mandatory — monthly committee review

What This Site Covers​

  • Getting Started — definitions, NMRA structure, MAH model, two-step market entry
  • Classification — EU-derived general classes + IVD A–D, SaMD, borderline
  • Registration Pathway — MAH, consolidated dossier, MDEC review, reliance, foreign facility, import licence
  • Pre-Market Requirements — technical docs, clinical evidence, special device types
  • Quality System — ISO 13485, manufacturing site registration, GMP inspection / waiver, GDP
  • Digital Health — SaMD framework, AI/ML, cybersecurity, IEC 62304
  • Post-Market — vigilance, FSCAs, PMS, advertising controls, annual fees
  • MAH & Facility Oversight — MAH obligations, NMRA site registration, GDP, MDEC, price regulation
  • Enforcement — Market Control Division, enforcement actions, penalties, import interception
  • Legislation — NMRA Act, classification guidelines, F-MDR-035, reliance guidelines
  • Special Access — WOR, radiation devices, custom-made devices

Part of the RAPath suite.

Post-Market Requirements

After Registration Certificate issuance, the MAH is responsible for: (1) reporting all adverse events to NMRA within speci