Medical Device Registration and Approval in Kenya

General country-specific regulatory information is provided on this page for medical device registration and approval in Kenya. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Kenya, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Kenya

REGULATORY AUTHORITY: The regulatory authority in Kenya is the Pharmacy and Poisons Board (PPB).

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes A-D, with A being the lowest risk and D being the highest.

TIMEFRAME: The registration process lasts for 90 days, after the application has been accepted and the evaluation fees have been paid for.

LICENSE VALIDITY: Licenses issued in Kenya expire after five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

Last updated on January 29 2015.

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