2019 First Medical Device Innovation and Development Summit Showcases in Guangzhou

      Many distinguished guests and elites gathered. A "brainstorm" event—the "2019 First Medical Device Innovation and Development Summit"—organized by the China Health Media Group, focusing on medical device innovation, was launched in Guangzhou.Themed "Innovation Leading Development, Quality Building the Future," this summit delved into cutting-edge topics of industry concern, such as medical device registration management regulations and policies, and innovative medical device technology applications, actively exploring the path of innovative development in medical devices. Wu Shaozhen, Chairman of the China Health Media Group, presided over and delivered a speech.

　　At the summit, Du Huiqin, Deputy Director of the Medical Device Registration Management Department of the National Medical Products Administration, interpreted relevant innovative policies on medical device registration management. Since the 18th National Congress of the Communist Party of China, the innovation-driven development strategy has become a national strategy. The national drug regulatory authorities have fully implemented the national strategy, continuously introducing measures to encourage innovation, and have achieved remarkable results in promoting innovation-driven industrial development.

　　Since2014, since the implementation of the "Special Approval Procedures for Innovative Medical Devices (Trial Implementation)", the number of products that have entered the special approval channel and obtained approval has maintained steady growth.

　　In 2019, innovative medical devices continued to emerge, and the number of invention patents in the medical device field also showed an upward trend. In 2018, during the reform of the drug and medical device review and approval system, the drug regulatory authorities successively issued and implemented the "Guiding Principles for the Design of Clinical Trials of Medical Devices" and the "Technical Guiding Principles for Accepting Overseas Clinical Trial Data of Medical Devices," continuously expanding the catalog of exemptions from clinical trials, aiming to formulate technical requirements for clinical trial design, avoid conducting repetitive clinical trials, improve the quality of clinical evaluation, and reasonably set requirements for clinical evaluation data. The introduction and implementation of these measures have made positive contributions to ensuring public safety in the use of medical devices, protecting the health of the people, and promoting industrial development.

　　Representatives from the National Medical Products Administration Center for Medical Device Evaluation, the China National Institute for Food and Drug Control, the Ministry of Industry and Information Technology's China Academy of Information and Communications Technology, the Ministry of Science and Technology's China Center for Biotechnology Development, and the China Pharmaceutical Regulatory Research Association, among other units, associations, and institutions, gave speeches at the meeting on medical device review and approval, the development of medical artificial intelligence, and the innovative development of the medical device industry. Representatives from Omron Healthcare (China) Co., Ltd. and Shanghai Yisi Medical Technology Co., Ltd. shared their experiences in chronic disease management model innovation and medical device product innovation, as well as their outlook on the future of smart healthcare and the global medical device market.

　　This summit was hosted by China Health Media Group Tianhe Exhibition Co., Ltd., China Pharmaceutical News, and China Food and Drug Administration Website, and received strong support from the Guangdong Provincial Drug Administration. The summit aims to create an interactive platform for communication between regulatory authorities and enterprises, a display and leading platform for industry and enterprise exchanges, to convey and interpret the latest and most authoritative regulatory dynamics, share and exchange the most cutting-edge information on industry R&D, gather the strength and consensus of all parties, promote the implementation of national policies and regulations encouraging medical device innovation, and contribute to the scientific research of medical device industry supervision and the high-quality innovative development of the medical device industry. During the summit, innovative medical device technology seminars, medical device clinical evaluation seminars, hemodialysis product seminars, artificial intelligence medical device application and implementation seminars, and in vitro diagnostic reagent product seminars were held.More than 300 representatives from the drug regulatory system, medical device companies, industry associations, and universities attended the meeting, sharing the innovation feast of the medical device industry.