On July 10th, 2023, the National Medical Device Safety Promotion Week was launched in Beijing. Xu Jinghe, Deputy Director of the National Medical Products Administration, revealed at the launch ceremony that in recent years, China's medical device regulatory work has made significant progress, the medical device industry has flourished, many high-end medical devices have been approved for listing, and public health rights and interests have been better protected. In 2022, the main operating revenue of medical devices in China reached 1.3 trillion yuan, becoming the second largest market in the world.

　　It is reported that in 2014, the National Medical Products Administration issued the 'Special Approval Procedure for Innovative Medical Devices (Trial)', and in December of the same year, the first innovative medical device was approved for market. As of now, the National Medical Products Administration has approved 217 innovative medical device products, including heavy ion therapy systems, proton therapy systems, surgical robots, artificial blood vessels, and many other high-end medical devices, achieving a double harvest in both quantity and quality.

　　In the review of medical device products, the National Medical Products Administration has established a working mechanism that shifts the focus of medical device technical evaluation to the product development stage. The emphasis is on products that may achieve breakthroughs in key technologies, key materials, and core components, and have independent intellectual property rights. Early guidance is provided to accelerate key core technology research and development, and to promote major breakthroughs in high-end medical devices in China through targeted approaches. Domestic products such as 'brain pacemakers', 5.0T magnetic resonance imaging systems, and third-generation artificial hearts continue to be launched, achieving breakthroughs in the domestic production of high-end medical devices and solving the situation where some products heavily rely on imports.

　　Xu Jinghe introduced that currently, China has formed a regulatory system for the full life cycle management of medical devices, led by the 'Regulations on the Supervision and Administration of Medical Devices', supported by 13 relevant supporting regulations, more than 140 normative documents, and more than 500 registration technical review guidelines; 1937 medical device standards were released, with a consistency level of over 90% with international standards; Collaborate with multiple departments to establish two innovative cooperation platforms for artificial intelligence medical devices and biomaterials; Establish two medical device evaluation and inspection sub centers in the Yangtze River Delta and the Greater Bay Area, as well as seven medical device innovation service stations, to continuously stimulate the high-quality development vitality of industrial innovation.

　　In the future, we will continue to promote the scientific research and application of medical device regulation, adding momentum to the innovative development of the industry, 'said Xu Jinghe.