Regulatory updates from IMDRF Management Committee and Official Observers including short updates from IMDRF Working Groups
Australia - Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division, TGA
Brazil - Augusto Bencke Geyer, General Manager, General Management of Health Product Technology, ANVISA
Canada - Sally Prawdzik, Acting Director, Policy and International Programs, Health Canada
China - Yuan Peng, Division Director, Department of Medical Device Registration, NMPA
European Union - Nada Alkhayat, Policy Officer, Directorate General for Health and Food Safety, European Commission & Chloe Spathari, Policy Officer, Directorate General for Health and Food Safety, European Commission
Information session: EU Medical Devices Regulation – extension of the transition period explained
The aim of this information session is to explain the EU Medical Devices Regulation (MDR) amendment adopted in March 2023 (Regulation (EU) 2023/607) and discuss its practical implementation from different angles.