Conference & Workshop
【Update Date:2018-10-03】unit:企劃及科技管理組
Center for Measurement Standards, ITRI, accepted the commission from the Food and Drug Administration to hold “Conference on International IVD Medical Devices Regulations”, inviting Mr. Stephen Lee, UK Medicines and Healthcare Products Regulatory Agency (MHRA) Biosciences Team Manager, Ms. Nuning Lestin Bintari, MOH senior inspector, Dr. Donald Powers, ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems chairman, Ms. Shelley Tang, Australia Therapeutic Goods Administration (TGA) retired official, Dr. Isabell Loftin, Companion Diagnostics expert from Roche, Mr. Tero Laulajainen, clinical trial expert, and Ms. Samara Zhu, China IVD industry representative to share experience on requirements and major changes in vitro diagnostic medical device regulations, the development of regulatory trends in important regions such as the EU and ASEAN, risk management of in vitro diagnostic medical devices, ISO/TC 212 activities, regulations on the introduction and clinical trials/evaluation of new products, etc.; there were 239 participants from 146 units of related industry, government, academic, research, medical circles.