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The Regulatory Compliance Unit of the South African Health Products Regulatory Authority (SAHPRA) is mandated to ensure that the marketing and promotion of medicines, scheduled substances, medical devices, and in vitro diagnostic medical devices (IVDs), for both human and veterinary use, comply with the Medicines...

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...