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.
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, Lesotho, Liberia, Madagascar, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, South Sudan, Swaziland, Tanzania, Togo, Zanzibar
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