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A high-tech digital illustration shows a robotic assistant interacting with a glowing human hologram and floating medical icons (brain, heart, and meditation) in a laboratory. This image represents the Pharmacy and Poisons Board’s April 2026 launch of regulatory guidelines for Medical Device Software (MDSW) and AI-powered technologies in Kenya, highlighting the intersection of advanced software and patient safety standards.
Technology
Kenya Introduces New Rules to Regulate AI and Medical Software in Healthcare
Juma Nasimiyu Centrine April 16, 2026

The Pharmacy and Poisons Board (PPB) has introduced a new guideline to regulate Medical Device Software (MDSW) as Kenya responds to the rapid growth of digital health technologies. The framework sets out clear rules for software used in healthcare, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). According to

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