Medical Device Regulatory Requirements in Rwanda
| Regulatory Authority |
Rwanda Food and Drugs Authority |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
A,B,C,D |
| Medical Device Regulations |
Medical Device Inspections Regulation
Guidelines on Submission of Documentation for
Registration of In Vitro Diagnostics Devices
(Same Regulations for IVD)
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
Guidelines for Submission of Documentation for Registration of In Vitro Diagnostics Devices |
| Registration Process |
Regulations Governing the registration of Medical Devices including In Vitro Diagnostics
| Click Here
|
| Registration Timeline |
8 to 10 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
All medical devices intended to be marketed in Rwanda shall be labelled in at least one of the official languages used in Rwanda according to the relevant |
| Additional Information |
The validity of registration certificate 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 We are not responsible for errors, omissions, or outdated content.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