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, free of charge, 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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