Can I read SAHPRA Medical Device Vigilance Guidelines on EtoBox?

SAHPRA Medical Device Vigilance Guidelines by kavathiaabhi1 is a document available to read on EtoBox.

What is SAHPRA Medical Device Vigilance Guidelines about?

This guideline outlines the requirements for reporting adverse events related to medical devices and in vitro diagnostics (IVDs) in South Africa, emphasizing the responsibilities of license holders and certificate holders. It details the definitions of reportable adverse events, the legal provisions, and the vigilance system established by the South African Health Products Regulatory Authority (SAHPRA) to ensure the safety and performance of medical devices. The document also includes the history of amendme

Author

kavathiaabhi1

Language

EN