State Food and Drug Administration held a report on innovative medical devices

, the State Drug Administration held an innovative medical device report meeting to showcase the innovative development of my country's medical device industry and the results of the reform of the review and approval system, exchange and share medical device innovation R & D and application experience, in order to further promote the innovation of my country's medical device industry High-quality development assistance. Relevant responsible comrades of the Equipment First Department of the Ministry of Industry and Information Technology, the Social Development Department of the Ministry of Science and Technology, and the Medical Department of the National Health Commission attended the meeting and delivered speeches. Xu Jinghe, member of the leading party group and deputy director of the State Food and Drug Administration, attended the meeting and delivered a speech.

meeting, the State Food and Drug Administration introduced the support measures and review of innovative medical devices in recent years. Eight innovative medical device enterprises, including Shanghai lianying medical technology co., ltd., Lanzhou kejin taiji new technology co., ltd., aerospace taixin technology co., ltd., Shanghai meijie medical technology co., ltd., Jiangsu baiyouda life technology co., ltd., Nanjing rongsheng medical technology co., ltd., Beijing aikangyicheng medical equipment co., ltd. and Guangzhou burning stone medical laboratory co., ltd., introduced high-end imaging equipment, ltd. Research and development, transformation and clinical application of innovative medical devices such as blood vessels, biliary stents, customized orthopedic implants, and in vitro diagnostic reagents, in recent years, relevant departments have implemented the innovation-driven development strategy, deepened reforms, and introduced a series of incentive measures to promote the innovation and development of medical devices.

Shanghai United Film Medical Technology Co., Ltd. said that China's high-end medical equipment industry has experienced a "golden decade" of rapid rise from scratch, thanks to the increasingly powerful national comprehensive economic strength, increasingly perfect regulatory science policy and the general trend of close integration of industry, University, research and medicine. Lanzhou Kejin Taiji New Technology Co., Ltd. advocates that medical device research and development should adhere to the world's scientific and technological frontier, the main economic battlefield, the major needs of the country, and the lives and health of the people, and in-depth implementation of the innovation-driven development strategy. Aerospace Taixin Technology Co., Ltd. proposed that enterprises should proceed from clinical needs, standardize clinical trials, optimize process and quality management, and constantly improve the safety and effectiveness of products. Shanghai Meijie Medical Technology Co., Ltd. believes that through the construction of achievement transformation system and mechanism, colleges and universities can build a deep integration system from interdisciplinary, project construction, interdisciplinary platform construction to industry university research cooperation, which is conducive to the cultivation and support of innovative products. Jiangsu Baiyouda Life Technology Co., Ltd. stated that it will innovate the support policies for medical devices, accelerate the application of products on the market, realize independent control of high-end medical devices, and better protect the lives of the people. Nanjing Rongsheng Medical Technology Co., Ltd. believes that the introduction of special review procedures for innovative medical devices and the establishment of innovative approval channels have played a positive role in building a communication platform between enterprises and professional reviews and speeding up the listing process of innovative products. In addition, A series of supporting policies issued by local governments, the state encourages medical device companies, universities and scientific research institutions to carry out industry-university-research cooperation and joint development policies, it provides a better environment and guarantee for the development of industrial innovation. Beijing Aikang Yicheng Medical Equipment Co., Ltd. proposed that the introduction of a customized medical device system is itself a system innovation. Through strict and standardized customized use and research and development, it is conducive to innovative medical device research and development, registration and listing. Guangzhou Burning Stone Medical Laboratory Co., Ltd. believes that with the policy support of the State Food and Drug Administration, the Ministry of Industry and Information Technology, the Ministry of Science and Technology, the National Health Commission and other departments to encourage innovative medical devices, products based on second-generation gene sequencing technology are quickly listed and applied to clinical practice, which greatly improves the level of patient diagnosis and treatment.

meeting stressed that medical devices are an important material basis for medical and health undertakings, which are related to people's life safety and health, and to the implementation of the strategy of healthy China and manufacturing power. The CPC Central Committee and the State Council attach great importance to it. In recent years, the State Food and Drug Administration has continued to improve the legal system, issued plans to promote high-quality industrial development, strengthened cooperation with relevant departments, innovated review mechanisms, initiated the implementation of regulatory scientific action plans, expanded regulatory international exchanges and cooperation, and continuously promoted industrial innovation and high-quality development. Up to now, 217 innovative medical device products have been approved, covering heavy ion therapy systems, proton therapy systems, surgical robots, artificial blood vessels and many other high-end medical devices. Some products are close to or reach the international advanced level, and the clinical application value is significant, filling my country. Blank in related fields.

meeting pointed out that the drug regulatory authorities will take this innovation report as a new starting point, face the new opportunities and requirements brought about by the scientific and technological revolution and industrial development, deepen the reform of the examination and approval system with a broader vision, a more positive attitude and more powerful measures, promote the high-quality development of industrial innovation, and further create a better ecological environment that encourages and supports the innovation of the medical device industry. Stimulate the vitality of industrial innovation to the greatest extent, contribute to the high-quality development of industrial innovation. At the same time, it is necessary to further strengthen the quality and safety supervision of the whole life cycle of innovative medical devices, ensure product quality and safety, and better protect and promote public health.

, responsible comrades of relevant departments and directly affiliated units of the State Drug Administration, China Medical Device Industry Association and more than 90 approved innovative medical device companies attended the meeting.