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EXPRESSION OF INTEREST FOR DEVELOPMENT OF SOFTWARE AS A MEDICAL DEVICE (SaMD) GUIDELINE FOR USE BY THE PHARMACY AND POISONS BOARD

The Pharmacy and Poisons Board (PPB) is the National Regulatory Authority mandated to protect the health of the public by regulating the profession of pharmacy and ensuring quality, safety and efficacy of medical products and health technologies in Kenya. In view of its regulatory functions, the PPB seeks to enhance its regulatory status by attaining the WHO categorization of Maturity Level 3 (hereinafter referred to as "ML.3") in line with the WHO Global Benchmarking Tool (GBT). PPB Conducted the Piloting of the GBT Tool +Medical
Devices (MD) in 2022 during the WHO-Benchmarking exercise conducted from June/July 2022. From this exercise regulatory oversight of Software as a Medical Device (SaMD) was identified as a gap.
The development and implementation of this guidance document wil support the regulatory oversight of Software as a Medical Device (SaMD) by the PPB.

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