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, free of charge, 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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