Medical Device Registration in

Sri Lanka

Ministry of Health

Ministry of Health

Regulatory Authority

National Medicines Regulatory Authority (NMRA)

Medical Device Regulation

National Medicines Regulatory Authority Act No. 05 of 2015

Official Language

Sinhala, Tamil

Classification

Class I, IIa, IIb and III

Registration Process

  • Determine the device classification
  • Appoint an Authorized Representative
  • Prepare the administrative documentation, addressed to Director CDDA, and apply for a sample license. On payment of fees, the application and a yellow receipt (issued by the MoH) will be entered in a register.
  • 3 copies of the sample license will be issued, with a validity of 1 year.
  • Prepare the Registration Dossier.
  • The local agent shall submit the dossier and product samples
  • Once approved, the Registration certificate will be granted.
  • The manufacturer can then apply for Import License.

Documents Required

  • Request letter for registration
  • Business registration certificate
  • Authorization Letter
  • Free Sales Certificate
  • Sample license
  • Certificate from the manufacturing country
  • List of countries with prior approval
  • Registration Dossier
  • Product samples
  • Labels, IFUs
  • Test Reports, Clinical Studies Reports,
  • QMS certificate
  • CE certificate

Legalised/Notarised Documents (if any)

Free Sales Certificate

Post-market Requirements

The serious adverse events should be reported within 24 hours. Any suspected AE should be reported as soon as possible.

Applicable QMS

ISO 13485

Authorized Representative

Yes. Marketing Authorization Holder

License Validity

  • Full registration – 5 years
  • Provisional registration – 1 year

Special Notes

  • The application should be prepared in 2 separate files
  • Medical devices with different components will require a separate application

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