Medical Device Registration in
Sri Lanka
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