PPB recognised as MDSAP as affiliate member, enhancing Medical Device Regulatory Standards in Kenya

The Pharmacy and Poisons Board (PPB) has attaining official recognition as an MDSAP Affiliate Member for the Medical Devices Single Audit Program (MDSAP).

This acknowledgment was made during the ongoing 25th session of the International Medical Devices Regulators Forum (IMDRF) in Washington DC from March 11th to March 14th, 2024.

Dr. Paulyne Wairimu, Chair of the African Medical Devices Forum and PPB’s Medical Devices Lead, along with Dr. Kariuki Gachoki, Director of HPTs, are representing PPB at this event, hosted this year by the US-FDA as Secretariat.

By joining a network of regulators including U.S. Food and Drug Administration, UK-Medicines & Healthcare products Regulatory Agency (MHRA), Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Australia’s Therapeutic Goods Administration (TGA), and Brazil’s The Brazilian Health Regulatory Agency (ANVISA), PPB is now empowered to conduct quality audits for medical devices and diagnostics.

This initiative aims to enhance regulatory standards in Kenya, aligning them with those of IMDRF member economies.

PPB’s leadership in Africa is underscored by its commitment to implementing a robust regulatory system for medical devices, further solidifying its position as a key player in advancing healthcare standards across the continent.