Guidelines on Clinical Evaluation of Medical Devices

This guideline is intended to clarify the requirements of conducting a clinical evaluation of a medical device in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and performance of medical devices under clinical investigation. It is not intended as an exclusive approach. The Authority reserves the right to request any additional information to establish the safety, quality and performance of a medical device in keeping with the knowledge current at the time of evaluation. Alternative approaches may be used but these should be scientifically and technically justified. The Authority is committed to ensure that all registered medical devices will be of the required acceptable quality, safety and performance.