14/04/2026
📢 Invitation to Industry Stakeholders
The South African Health Products Regulatory Authority (SAHPRA) invites industry stakeholders to a targeted stakeholder engagement session focused on training and guidance on Adverse Event reporting requirements.
This engagement aims to strengthen understanding and implementation of Regulation 17 of the Regulations Relating to Medical Devices, including In Vitro Diagnostic Medical Devices (IVDs). The session supports regulatory compliance, enhances post‑market surveillance, and promotes the safety, performance, and quality of medical devices in South Africa.
🔍 Key focus areas include:
• Identification, assessment, and reporting of adverse events and near‑adverse events
• Clarification of legal obligations and reporting timelines
• Guidance on submission processes and applicable regulatory guidelines
This session is essential for stakeholders involved in the lifecycle of medical devices within the South African market.
📌 Stay engaged. Stay compliant. Strengthen patient safety.
Register here: https://bit.ly/4tcSUK6