Medical Device Regulatory Requirements in Ghana
| Regulatory Authority |
Ghana Food and Drug Authority |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I,II,III,IV |
| Medical Device Regulations |
Public Health Act, 2012 (Same Regulations for IVD)
| Click Here
|
| IVD Classification |
I,II,III,IV |
| In Vitro Diagnostics Regulations |
Guideline for Registration of Medical Device |
| Registration Process |
Guideline for Registration of Medical Device
| Click Here
|
| Registration Timeline |
6 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in English Language |
| Additional Information |
Applications for renewal of registration shall be made at least 3 months before the expiry of existing registration |
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 We are not responsible for errors, omissions, or outdated content.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