REGULATORY AUTHORITY: Medical devices are regulated by the Tanzanian Food and Drugs Authority (FDA).

CLASSIFICATION SYSTEM: Devices are classified according to risk into Classes A, B, C, and D.

TIMEFRAME: Once an application has been accepted and paid for, the evaluation process will take up to 270 days.

LICENSE VALIDITY: Licenses issued in Tanzania are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

LICENSE TRANSFER: License transfer from one Authorized Representative (AR) to another is possible. The Marketing Authorization Holder (MAH) must complete the form for the change of local technical representative and submit it along with the other documents specified in the application form.

ADDITIONAL INFORMATION: Medical Devices (MDs) and In Vitro Diagnostic devices (IVDs) classified as Class A — that are non-active, non-sterile, and without a measuring function — are exempted from registration. However, despite being exempted, such devices must still be notified to the authority through the online portal (https://imis2.tmda.go.tz/), after which an approval letter will be issued.

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, Togo, Zanzibar