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.
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