Zanzíbar Food and Drug Agency (ZFDA)
Both medical devices and IVDs are following this risk classification:
Medical device registration: vary from 60 to 150 days depending on risk classification
IVD device registration: up to 270 days
Local testing: certain diagnostics equipment such as analysers will require a local testing, but this is only requested once the reviewer is not satisfied with the presented data.
On-site inspection: an on-site inspection to a foreign manufacturing facility will be required for class B, C and D devices.
PRODUCT REGISTRATION MD:
From 200 US$ to 1000 US$ – depending on the class of the device
PRODUCT REGISTRATION IVD:
From 100 US$ to 1000 US$ – depending on the class of the device
LOCAL FEES (Manufacturer):
On-site inspection fees vary from USD 4000-8000 depending on the location of the manufacturing facility.
The issued license will be valid for 5 years. The renewal application must be submitted 90 days before the license expiry date.
Transferring license from one authorized representative to another is possible.
A foreign manufacturer must appoint a local company that has obtained a medical device establishment license to become their authorized representative. Proof of official appointment shall be submitted to ZFDA.
•Marketing authorization license will remain issued once the application for on-site audit is paid and submitted (conditional approval).
•Certain medical devices, due to low risk associated of their use, are exempted from the product registration requirement. Although exempt, a notification to ZFDA is still required.
Other Sub-Saharan African Countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Comoros, Congo, DR Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea – Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, South Sudan, Swaziland, Tanzania, Togo