Medical Device Regulatory Requirements in Kenya
| Regulatory Authority |
Pharmacy and Poisons Board (PPB) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
A,B,C,D |
| Medical Device Regulations |
Guidelines for Registration of Medical Devices including in-vitro diagnostics (Same Regulations for IVD)
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
Guidelines for Registration of Medical Devices including in-vitro diagnostics |
| Registration Process |
Guidelines for Registration of Medical Devices Establishments
| Click Here
|
| Registration Timeline |
around 10 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in English Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
A medical devices establishment registration certificate shall expire on 31st December each year and it is renewable annually. The registration certificate for manufacturers will be valid for five years following a successful reinspection |
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 We are not responsible for errors, omissions, or outdated content.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