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.
Purpose:
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.
Agenda
Day 1
Recording
Presentations
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
Agnes Kijo, World Health Organization, WHO
Introduction and Overview on Good Regulatory Practices (GRPs): Global and Domestic
Global: WTO, OECD – Marina Carvalho, MDRC
Domestic:
Dineo Hexana, SABS
Lydia Motlogelwa, SAHPRA
Implementation of a Quality Management System for the regulatory processes of a National Regulatory Authority – Nancy Braier, US FDA
Implementation of Good Regulatory Practices by National Regulatory Authorities: US FDA – Kristan Callahan, US FDA
Day 2
Recording
Presentations
Overview of Medical Devices (MDs)
Tanya Vogt, SAMED
Dirk Gey van Pittius & Fatemeh Razjouyan, Medtronic
Overview of IVDs
Sarah Cohen, SALDA
Asmaa Awad, Roche Diagnostics
Risk Classification of Medical Devices and IVDs – International References – Part I: Medical Devices IMDRF References – Rama Sethuraman, HSA
Risk Classification of Medical Devices and IVDs – International References – Part II: IVDs IMDRF References – Rama Sethuraman, HSA
Risk Classification of Medical Devices and IVDs – Domestic Regulation – Khanyisile Nkuku, SAHPRA
Essential Principles of Safety and Performance – Part I – IMDRF References – Augusto Geyer, ANVISA
Day 3
Recording
Presentations
International Standards. Its role in the Regulation of Medical Devices & IVDs – Tracey Duffy, TGA
International Standards Management and Practical Application at a National level. The When, How and Who
Mapaseka Gumbi, SABS
Simone Rudolph-Shortt, MDMSA
Jeff Eggleston (Fatemeh Razjouyan), Medtronic
Reliance applied to Medical Devices & IVDs – International References and Experience of National Regulatory Authorities – Part I
Agnes Kijo, WHO
Wong Woei Jiuang, HSA
Reliance applied to Medical Devices & IVDs – International References and Experience of National Regulatory Authorities: ANVISA – Augusto Geyer, ANVISA
Reliance applied to Medical Devices & IVDs – International References and Experience of National Regulatory Authorities: TGA – John Jamieson, TGA
Reliance applied to Medical Devices & IVDs – International References and Experience of National Regulatory Authorities: SAHPRA – Dimakatso Mathibe & Khanyisile Nkuku, SAHPRA
Conformity Assessment – Amy Phelps, National Institute of Standards and Technology (NIST)
Conformity Assessment. The domestic perspective – Tumelo Ledimo, SANAS
