• 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

• Japan - Tomoyuki Miyasaka, Deputy Director, Medical Devices Evaluation Division, MHLW
• Singapore - Wong Woei Jiuang, Assistant Group Director, Medical Devices Cluster, HSA
• South Korea - Jeong-Rim Lee, Director General, Medical Device Evaluation Department, MFDS
• United Kingdom - Laura Squire, Chief Healthcare Quality and Access Office, Medicines and Healthcare products Regulatory Agency (MHRA)
• United States of America - Kenneth Cavanaugh, Deputy Director, Office of Cardiovascular Devices, US FDA

Official observers:

• Argentina - Yesica Anastasio, Coordinator of the International Relations Program, National Administration of Drugs, Food and Medical Devices (ANMAT)
• Switzerland - Markus Wälti, Head of Division, Swiss Agency for Therapeutic Products (Swissmedic)
• World Health Organization (WHO) - Hiiti Baran Sillo, Unit Head, Regulation and Safety Department of Regulation and Prequalification

• African Medical Devices Forum (AMDF) - Paulyne Wairimu, Chair
• Asia Pacific Economic Cooperation (APEC) - Cheng-Ning (Emily) Wu, Senior Technical Specialist, Division of Medical Devices and Cosmetics, Taiwan Food and Drug Administration
• Global Harmonization Working Party (GHWP) -  Bryan So, Executive Secretary General
• The Global Diagnostic Imaging, Healthcare ICT, and Radiation Therapy Trade Association (DITTA) - Patrick Hope, Chair
• Global Medical Technology Alliance (GMTA) - Diana Kanecka, Senior Manager International Affairs, MedTech Europe

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.