Medical Devices Registration Feasibility Study report

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 and define an effective, risk-based approach for the registration of medical devices including IVDs intended for human use, encompassing both locally manufactured and legally imported products.