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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Tanzania, to expedite the preparation of your medical device or IVD registration application.

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.

Last updated on January 29 2015.

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