REGULATORY AUTHORITY: Medical devices and IVDs are regulated by the Zanzíbar Food and Drug Agency (ZFDA).
CLASSIFICATION SYSTEM:
Both medical devices and IVDs follow a risk-based classification system Class A, Class B, Class C, and Class D.
TIMEFRAME:
Medical devices:
- Class A: ~60 days
- Class B, C, D: up to 150 days
IVDs:
- All classes: up to 270 days
LICENSE VALIDITY:
Licenses issued by ZFDA are valid for 5 years.
Renewal applications must be submitted at least 90 days before expiry.
LOCAL FEES (New Application):
- Medical devices: USD 200–1000 (depending on class)
- IVDs: USD 100–1000 (depending on class)
LICENSE TRANSFER:
License transfer from one authorized representative to another is permitted.
AUTHORIZED REPRESENTATIVE:
A foreign manufacturer must appoint a local company licensed by ZFDA as its authorized representative. Proof of official appointment must be submitted.
ADDITIONAL INFORMATION:
- Marketing authorization may be issued on a conditional basis once the on-site inspection application is paid and submitted.
- Class A medical devices and IVDs that are non-active, non-sterile, and without a measuring function are exempt from product registration; however, notification to ZFDA is mandatory.
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
