Medical Device Regulatory Requirements in Tanzania
| Regulatory Authority |
Tanzania Food and Drug Authority |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
A,B,C,D |
| Medical Device Regulations |
The Tanzania Food, Drugs and Cosmetics (Control of Medical Devices) Regulations, 2015
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
In Vitro Diagnostics Devices Guidelines |
| Registration Process |
Guidelines on Submission of Documentation for Registration of Medical Devices
| Click Here
|
| Registration Timeline |
Around 8 to 9 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in English Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
The registration of a medical device shall be valid for five (5) years unless suspended or revoked by TMDA or terminated by the registrant. |
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 We are not responsible for errors, omissions, or outdated content.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