South Africa’s medical device regulatory landscape is changing rapidly.

Stay ahead by hearing directly from SAHPRA on evolving regulatory priorities, licensing and registration pathways, compliance expectations, and plans to improve regulatory efficiency. Gain practical insights, ask your pressing questions during the live Q&A with the SAMED Regulatory Committee, and ensure your organisation is prepared for the regulatory developments shaping the future of the medical technology and IVD sector.

Programme

10:00 – 11:30 | SAHPRA’s Regulatory Roadmap for Medical Devices and IVDs

• Gaopalelwe Kelatwang, Manager: Medical Devices and IVDs (Licensing, Vigilance and Compliance), SAHPRA
• Lydia Motlogelwa, Medical Device Registration Manager, SAHPRA

11:30 – 12:15 | Q&A with the SAMED Regulatory Committee

We encourage attendees to raise their most pressing regulatory questions. This interactive discussion is intended to collectively explore practical solutions to the challenges facing the medical devices and IVD sector.

To help us prepare, please submit your questions in advance to Nomthi Mnisi at communication@samed.org.za

Who Should Attend

• Regulatory Affairs Professionals
• Quality Assurance and Quality Management Teams
• Compliance Managers
• Executive and General Managers
• Medical Device and IVD Manufacturers
• Importers and Distributors
• Legal and Risk Professionals
• Market Access and Government Affairs Specialists
• Clinical Affairs Professionals
• Anyone responsible for regulatory compliance, licensing, registration, or post-market activities within the medical technology sector.

This event is free for SALDA, MDMSA, and the Western Cape Medical Devices Cluster members only.

To register: Click Here