Industry Meeting on Adverse Event Reporting for Medical Devices (including IVDs)

The South African Health Products Regulatory Authority (SAHPRA) hosted an engagement session focused on training and guidance regarding SAHPRA’s requirements for Adverse Event reporting.

The purpose of the engagement was to enhance industry understanding and facilitate the effective implementation of Regulation 17 of the Regulations Relating to Medical Devices, including In Vitro Diagnostic Medical Devices (IVDs). This initiative supported regulatory compliance, strengthened post‑market surveillance activities, and promoted the safety, performance, and quality of medical devices placed on the South African market.

Recording