REGULATORY AUTHORITY:
Zanzíbar Food and Drug Agency (ZFDA)
CLASSIFICATION SYSTEM:
Both medical devices and IVDs are following this risk classification:
•Class A
•Class B
•Class C
•Class D
TIMEFRAME:
Official Timeline
Medical device registration: vary from 60 to 150 days depending on risk classification
IVD device registration: up to 270 days
SPECIAL REQUIREMENTS:
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.
LICENSE VALIDITY
The issued license will be valid for 5 years. The renewal application must be submitted 90 days before the license expiry date.
LICENSE TRANSFER
Transferring license from one authorized representative to another is possible.
AUTHORIZED REPRESENTATIVE
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.
ADDITIONAL INFORMATION
•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
