An Insight Into Medical Device Requirements in Kenya

The Kenyan Pharmacy and Poisons Board have released draft guidance (January 2012) specifying minimum requirements for advertising and promoting drugs and medical devices. The document is aimed at ensuring the legal framework is adhered to and that the message received by consumers from therapeutic goods manufacturers is factual and evidence based.

Drug and device manufacturers and distributors are responsible for the statements and activities of their sales and marketing representatives and must ensure the representatives working for them are authorised by the Kenyan Pharmacy and Poisons Board and comply with the requirements specified.

The guidance formalises that no medical device can be marketed without registration with the Kenyan Pharmacy and Poisons Board and that misleading statements cannot be made.

For a copy of the guidance or information regarding regulatory requirements in international markets, contact KD&A.