KENYA— The Pharmacy and Poisons Board (PPB) has been designated as an MDSAP Affiliate Member of the Medical Devices Single Audit Programme (MDSAP).
MDSAP creates, manages, and oversees a single audit program that enables a single regulatory audit of a Medical Device manufacturer, done by an MDSAP-recognised auditing company, to meet the needs of numerous regulatory authorities.
This announcement was made during the 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, and Dr. Kariuki Gachoki, Director of HPTs, represented PPB at this event, which was sponsored this year by the US-FDA as Secretariat.
PPB has now joined other MDSAP Affiliate Members, including Argentina’s National Administration of Drugs, Foods, and Medical Devices (ANMAT), the Ministry of Health of Israel, the Republic of Korea’s Ministry of Food and Drug Safety, Mexico’s Federal Commission for Protection from Sanitary Risks (COFEPRIS), Singapore’s Health Sciences Authority (HSA), and Taiwan Food and Drug Administration (TFDA).
Additionally, MDSAP also encompasses five participating regulatory authorities, such as the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW and PMDA), and the United States Food and Drug Administration (FDA).
Moreover, there are several MDSAP Official Observers, including the European Union (EU), the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), and the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program.
This effort intends to improve Kenya’s regulatory standards and align them with those of IMDRF member economies.
PPB’s leadership in Africa is demonstrated by its dedication to developing a strong regulatory system for medical devices, which strengthens its position as a significant participant in raising healthcare standards across the continent.
MDSAP minimizes the number of audits necessary by several regulatory bodies to certify a manufacturer’s ongoing compliance with the quality management system (QMS) standards of each MDSAP regulatory agency, saving time and eliminating disruptions to manufacturing operations.
Other advantages include increased acceptance of audit reports by participating authorities and more transparent and consistent oversight by regulators, including follow-up on audit findings.
Regulatory authorities can use MDSAP audit reports to analyze specific regulatory approval applications and incident reports.
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