Medical Device Regulatory Requirements in Sri Lanka
| Regulatory Authority |
National Medicines Regulatory Authority (NMRA) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
Listed devices, I,
IIa, IIb, III |
| Medical Device Regulations |
Medical Device Regulation
| Click Here
|
| IVD Classification |
A,B,C,D |
| Registration Process |
Medical Device Registration
| Click Here
|
| Registration Timeline |
6 to 8 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in English, Sinhala & Tamil Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
The validity of import license is 1 year and full registration is 5 years. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025