The Medical Device Regulatory Convergence (MDRC) Project in collaboration with the South African Health Products Regulatory Authority (SAPHRA) prepared Capacity Building Sessions on Good Regulatory Practices, Good Reliance Practices and International references. The event took place in Pretoria, South Africa from 14 to 16 November, 2023. National Regulatory Authorities from Australia, Brazil, Singapore, the United States of America and South Africa, along with subject matter experts from global and local manufacturers, shared their expertise with both regulators and the regulated sector.
This workshop will provide an exchange of information and capacity building between the South African Health Products Regulatory Authority, SAHPRA and partner reference NRAs including the WHO, USFDA, TGA, HSA, ANVISA, covering the core international references for medical device regulatory. The workshop objective is to support and advance to strengthen the soft infrastructure of medical device regulatory framework to incorporate global lessons learned from the COVID-19 pandemic, to better prepare for future health emergencies, to prevent the implementation of unnecessary regulatory barriers to medical technologies, to improve general MD NRA public administration and general public health.
Training Objectives and Overview – Dimakatso Mathibe, SAHPRA – coming soon!
MDRC Project Overview – Sandra Ligia González, MDRC
Overview of Medical Devices and IVDs. Where we are and where we are heading – Dimakatso Mathibe, SAHPRA – coming soon!
International Benchmarks for Medical Device Regulatory Frameworks and Authorities. Health References & Recommendations:
- WHO Global Model Regulatory Framework for Medical Devices and IVDs
- WHO Good Regulatory Practices