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The purpose of the Medical Device Registration Feasibility Study was to support the South African Health Products Regulatory Authority (SAHPRA) in advancing the implementation of a comprehensive regulatory framework for medical devices, including in vitro diagnostics (IVDs), within South Africa. The study aimed to evaluate...

Regulatory agencies on the African continent are beset by critical skill shortages caused in part by a lack of resources and training. While some of these issues are being addressed by the regulatory agencies themselves, there exists an urgent need for targeted training for clinical...