The Conference was divided into two stages, i.e. closed meeting and open meeting. At the closed meeting, importance was attached to the discussion on AHWP’s development objectives, three-year work planning, capability building and coordination of technology regulations as well as other key fields, such as electronic labels, in vitro diagnosis reagent supervision, supervision after listing, clinical evaluation, quality management system and standards and unique device identification (UDI); meanwhile, topics including artificial intelligence medical devices and 3D printing cutting-edge products of customized medical devices were studied and discussed. The presiding chairman of International Medical Device Regulators Forum (IMDRF) and the person chiefly in charge of the Department of International Cooperation of former China Food and Drug Administration delivered welcome speeches and introduced the latest progress of IMDRF’s rule-making; the representative of China Drug Administration introduced the supervision and industry development of medical devices in China at the meeting, and indicated that based on the Regulation on the Supervision and Administration of Medical Devices, China had built a relative perfect law and regulation system covering the full life circle, and with constant strengthening of standards, classification, unique device identification and other basic supervision work of medical devices, reform of evaluation and approval system for medical devices as well as encouragement for innovation were continuously further promoted, support capability for safety and effectiveness of medical devices and risk control level kept on improving, and while domestic demands for medical devices were met, China was able to provide more high-quality products to serve other countries and regions.
Zhao Yixin, President of CAMDI
Dr. Fan Xiaodong, Standing Vice President of CAMDI
The opening meeting was sponsored by China Association for Medical Devices Industry. President Zhao Yixin attended the meeting and delivered a speech, and Standing Vice President Dr. Fan Xiaodong presided over the meeting. The opening meeting introduced the general situation of AHWP, as well as the supervision regulations and latest progress for medical devices of the EU, the ASEAN, Saudi Arabia and Hong Kong, China. More than 60 representatives of enterprises of medical devices in the industry attended the meeting. These enterprises indicated that under the background of the “Belt and Road Initiative” policy, AHWP also provided a good platform and opportunity for Chinese enterprises to go global and drive the development of medical devices in Asian and even throughout the world.