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NMRA Act No. 5 of 2015

Primary legislation · Medical device registration framework

Purpose and Scope​

The National Medicines Regulatory Authority Act No. 5 of 2015 established the NMRA as an independent statutory authority under the Ministry of Health. It provides the comprehensive legal framework for:

  • Registration and licensing of medicines, medical devices, and borderline products
  • Establishment and governance of the NMRA and its committees
  • Licensing of manufacturers, importers, and distributors
  • Post-market surveillance and adverse event reporting
  • Advertising controls (prior approval requirement)
  • Enforcement powers and penalties
  • Fee collection authority

Key Provisions Affecting Medical Devices​

Device Definition​

The NMRA Act's definition of "medical device" captures instruments, apparatus, appliances, software, materials, and other articles intended by their manufacturer for human use in:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation or compensation for injury/handicap
  • Investigation, replacement or modification of anatomy or physiological processes
  • Control of conception

Section 77 — Labelling Requirements​

Section 77 of the NMRA Act specifies the minimum labelling requirements that all registered devices must meet. This section requires labels to include the device name, manufacturer details, MAH details, lot number, manufacturing date, expiry date, and other specified information.

Registration and Licensing Provisions​

The Act establishes the legal framework for:

  • The two-step market entry process (Registration Certificate + Import Licence)
  • MAH appointment and accountability
  • Foreign manufacturing facility registration
  • Conditional registration (subject to post-market requirements)

Advertising Controls​

A key provision of the NMRA Act requires prior written approval from the NMRA for all advertising of registered medical devices. Advertising without prior approval is a regulatory offence.

NMRA's Powers​

Under the Act, the NMRA can:

  • Recall any registered medicine, medical device, or borderline product
  • Inspect manufacturing, storage, and distribution facilities
  • Suspend or cancel Registration Certificates and Import Licences
  • Seize and destroy non-compliant products
  • Prosecute violations in appropriate courts

How to Access the NMRA Act​

The NMRA Act No. 5 of 2015 is available from:

  • NMRA official website: www.nmra.gov.lk
  • Sri Lanka Government Gazette archives
  • Sri Lanka Parliament website