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Medical Device Registration and Approval in Tanzania
General country-specific regulatory information is provided on this page for medical device registration and approval in Tanzania.
Last updated on November 25th, 2021.
Medical Device Regulations and Classification in Tanzania
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
For detailed device-specific compliance information for each market, including Tanzania, to expedite the preparation of your medical device or IVD registration application.
Any Questions?
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