Post Market Surveillance and Post-market Clinical Follow-up Studies

This guideline is intended to provide recommendations to Manufacturers, Importers, Exporters, Distributors, and Holders of certificates of Registration (HCR) of medical devices. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and performance of medical devices. 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 ensuring that all registered medical devices will be of the required quality, safety, and performance. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications. Guidelines and application forms are available from the SAHPRA website.