The Medical Devices Single Audit Programme (MDSAP) has officially recognised the Pharmacy and Poisons Board (PPB) as an MDSAP Affiliate Member, marking a noteworthy accomplishment.
This acknowledgment was given during the 25th International Medical Device Regulators Forum (IMDRF) meeting, which has been taking place in Washington, DC, from March 11–14, 2024.
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions.
PPB's dedication to establishing a strong medical device regulatory framework highlights its leadership in Africa and bolsters its standing as a major force in raising healthcare standards throughout the region.
PPB is now authorized to conduct quality audits for medical devices and diagnostics by joining a network of regulators that includes the Therapeutic Goods Administration (TGA) of Australia, the Brazilian Health Regulatory Agency (ANVISA), Health Canada, the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, the UK-Medicines & Healthcare Products Regulatory Agency (MHRA), and the Japanese PDA.
By aligning Kenya's regulations with those of IMDRF member economies, this program seeks to improve Kenya's regulatory standards.
By Vanessa Kariuki
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