The 2023 National Medical Device Safety Awareness Week was launched in Beijing on the 10th. Xu Jinghe, deputy director of the China Drug Administration (CFDA), revealed at the launching ceremony that in recent years, China’s medical device regulatory work has made great progress, the medical device industry is booming, many high-end medical devices have been approved and listed, and the public health rights and interests have been better safeguarded.In 2022, China’s medical device main business revenue reached 1.3 trillion yuan, becoming the second largest market in the world.
It is understood that in 2014, the State Drug Administration issued the Special Approval Procedures for Innovative Medical Devices (for Trial Implementation), and in December of the same year, the first innovative medical device was approved for listing. Up to now, the State Drug Administration has approved 217 innovative medical device products, and the approved products cover many high-end medical devices such as heavy ion therapy system, proton therapy system, surgical robot, artificial blood vessels, etc., which has achieved a double harvest in terms of quantity and quality.
In the review of medical device products, the State Drug Administration has established a working mechanism to shift the centre of gravity of technical review of medical devices to the stage of product research and development, focusing on the possible breakthroughs in key technologies, key materials, core components and products with independent intellectual property rights, and intervening in advance to guide and accelerate the research and development of key core technologies, so as to promote the breakthrough of China’s high-end medical devices by taking the lead in the face of the major breakthroughs. Domestic “brain pacemaker”, 5.0T magnetic resonance imaging system, third-generation artificial heart and other products continue to be listed, to achieve domestic breakthroughs in high-end medical devices, to solve the situation that some products are seriously dependent on imports.
Xu Jinghe introduced, at present, China has formed the “supervision and management regulations of medical devices” as the overall leader, 13 relevant supporting regulations, more than 140 normative documents, more than 500 registration technical review guiding principles for the support of the whole life cycle of the medical device management regulatory system; issued 1937 medical device standards, with international standards consistency of more than 90%; and with the cooperation of multiple departments, the establishment of the 2 innovation cooperation platforms for artificial intelligence medical devices and biomaterials; establish two medical device review and inspection sub-centres in the Yangtze River Delta and the Greater Bay Area and 7 medical device innovation service stations, and continuously stimulate the vitality of industrial innovation and high-quality development.
“In the future, we will continue to promote the application of medical device regulatory scientific research to add momentum to industrial innovation and development.” Xu Jinghe said.
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Post time: Jul-11-2023