| Regulatory Authority | Zanzibar Food and Drug Agency |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | A,B,C,D |
| Medical Device Regulations | Guidelines on Submission of Application for Registration of Medical Devices | 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 | Refer Guidance document for registration process |
| Registration Timeline | 3 to 5 months |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in English and/or Kiswahili Language |
| Database | ZFDA WebPortal | Click Here |
| Additional Information | The registration of a medical device shall be valid for five (5) years unless suspended or revoked by ZFDA or terminated by the registrant |