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Release date:2023-12-23

According to the National Medical Products Administration on July 11th, on July 10th, the National Medical Products Administration held an Innovation Medical Device Report Meeting to showcase the innovation and development of China's medical device industry and the achievements of the review and approval system reform, exchange and share experiences in the innovation, research, and development application of medical devices, and contribute to further promoting the highquality development of China's medical device industry. During the meeting, the National Medical Products Administration introduced the support measures and review situation of innovative medical devices in recent years. Eight innovative medical device companies, including Shanghai United Imaging Healthcare Co., Ltd., Lanzhou Kejintaiji New Technology Co., Ltd., Aerospace Taixin Technology Co., Ltd., Shanghai Meijie Medical Technology Co., Ltd., Ji-angsu Baiyouda Life Technology Co., Ltd., Nanjing Rongsheng Medical Technology Co., Ltd., Beijing Aikangyicheng Medical Equipment Co., Ltd., and Guangzhou Ranshi Medical Examination Co., Ltd., introduced the research, development, and transformation of innovative medical devices such as high-end imaging equipment, heavy ion treatment equipment, artificial hearts, tumor treatment, artificial blood vessels, biliary stents, customized orthopedic implants, and in vitro diagnostic reagents, as well as their clinical application effects. They gave positive evaluations to the relevant departments' impleme-ntation of the innovation-driven development strategy, deepening reform, issuing a series of encouraging measures, and promoting the innovation and development of medical devices.


The meeting emphasized that medical devices are an important material basis for medical and health undertakings, related to the safety and health of the people, and related to the implementation of Healthy China and the strategy of building a manufacturing powerhouse, which are highly valued by the CPC Central Committee and the State Council. In recent years, the National Medical Products Administration has continuously improved the regulatory system, formulated plans to promote the high-quality development of the industry, strengthened cooperation with relevant departments, innovated review mechanisms, launched the implementation of scientific regulatory action plans, expanded international exchanges and cooperation in regulation, and continuously promoted the   high-quality development of industrial innovation. As of now, 217 innovative medical device products have been approved, covering many high-end medical devices such as heavy ion treatment systems, proton therapy systems, surgical robots, artificial blood vessels, and some products are close to or reach the international advanced level, with significant clinical application value, filling gaps in relevant fields in China.


The meeting pointed out that the drug regulatory department will take this innovation report meeting as a new starting point, face the new opportunities and requirements brought by technological revolution and industrial development, with a broader vision, a more proactive attitude, and more effective measures, deepen the reform of the review and approval system, promote the high-quality development of industrial innovation, further create a more favorable ecological environment to encourage and support innovation in the medical device industry, maximize the stimulation of innovation vitality, and 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 entire life cycle of innovative medical devices, ensure product quality and safety, and better protect and promote public health.

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