Guideline Describes Device Registration Process in Kenya

Kenya’s Pharmacy and Poisons Board (PPB) has issued guidance on the documentation devicemakers and their local authorized representatives must submit in order to register a product there. Registration dossiers should include whether the product is marketed in the country of origin and its classification there, when it was introduced in the market, its registration number and the year and issuing agency of the conformity assessment certificate. Copies of certificates related to international standards and good manufacturing practice in the country of origin should also be submitted.
International Medical Device Regulatory Monitor