The 2025 National Work Conference on Medical Device Supervision and Administration was held in Shijiazhuang City, Hebei Province from January 16 to 17. Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, following the spirit of the 20th National Congress of the Communist Party of China (CPC) and the Second and Third Plenary Sessions of the 20th CPC Central Committee, and observing the requirements of the National Work Conference on Medical Products Administration, the conference summarized the work of 2024, analyzed the current situation, and deployed key tasks for 2025. Xu Jinghe and Lei Ping, members of the CPC Leading Group and Deputy Commissioners of the National Medical Products Administration (NMPA), attended the conference and delivered speeches.
The conference noted that in 2024, work was done to steadily advance law-based regulation work, introduce documents for the comprehensive deepening of regulatory reform, make steady progress in drafting the Medical Device Administration Law, and accelerate the formulation and revision of supporting systems; work was done to achieve significant results in the reform of the review and approval system, continuously increase innovative products, launch joint research on high-end products, and steadily implement regional strategies; work was done to further standardize local registration and filing, continuously strengthen supervision and guidance, intensify information disclosure, and accelerate capability evaluations; work was done to effectively launch consolidation and enhancement actions, promptly control risks and hidden dangers, thoroughly conduct inspections in key areas, and resolutely and effectively combat illegal acts; work was done to continuously strengthen product quality supervision and inspection, efficiently conduct sampling inspections in a targeted manner, innovate and upgrade monitoring and evaluation work, yield results in market order rectification, and deepen governance of online sales; work was done to steadily improve the regulatory system’s capabilities, continuously refine the standards system, optimize categorized management on an ongoing basis, effectively advance regulatory science research, accelerate the pace of informatization, and achieve fruitful results in international exchanges. These notable results in medical device supervision and administration strongly safeguarded the quality and safety of medical devices and effectively protected the public’s health rights and interests.
The conference emphasized that currently, the systems and mechanisms for developing new quality productive forces in China’s medical device industry are accelerating to become sounder and the medical device industry is still in its “golden period of development,” therefore, the entire system should accurately grasp the new situations and requirements facing regulatory work and keep advancing medical device regulation. The year 2025 is the concluding year of the 14th Five-Year Plan and the planning year for the 15th Five-Year Plan. The conference stressed the need to earnestly implement the “Four Strictest (strictest standards, regulation, punishment, and accountability)” requirements, follow the working ideas of “highlighting politics, enhancing regulation, securing safety, promoting development, and improving people’s wellbeing,” adhere to the general principle of pursuing progress while ensuring stability, and focus on coordinating development with safety, efficiency with fairness, and regulation with service. The conference emphasized the importance of deepening medical device regulatory reform throughout the process, strengthening the bottom line of medical device safety across the board, and supporting the high-quality development of the medical device industry across the chain, to effectively ensure the safety of people in using medical devices.
According to the conference, the document, Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation of Drugs and Medical Devices to Promote the High-quality Development of the Pharmaceutical Industry, is an important document for promoting the high-level safety and high-quality development of medical devices and achieving new heights in regulatory work at present and in the coming period, and it is important to further enhance the political stance, grasp work priorities, strengthen overall coordination, and focus on implementation, to ensure that various reform measures are implemented in a strong and orderly manner.
The conference required that medical device supervision and administration work should maintain alignment between regulatory capabilities and work needs, better coordinate and allocate regulatory resources, further strengthen risk governance, and optimize the frequency, quality, and effectiveness of enterprise inspections, and the work should put time and energy in work collaboration, exploration and pilot work, and investigative research to better coordinate development and safety and elevate medical device supervision and administration to a new level.
The conference deployed five key tasks for medical device regulation in 2025: to accelerate improving legal and standards systems as led by the formulation of the Medical Device Administration Law; to accelerate the marketing of high-end innovative medical devices by centering on deepening reform of the review and approval system; to accelerate improving compliance in the medical device industry with the goal of safeguarding the safety bottom line; to accelerate building systems and capabilities adapted to industry development and safety needs with practical training as the footing; and to accelerate the pace of opening-up and cooperation as oriented by enhancing the internationalization of regulation.
Delegates from the medical products administrations of Beijing, Hebei, Shanghai, Jiangsu, Guangdong, and Chongqing exchanged their views and delivered speeches. The principal responsible persons of the Department of Medical Device Registration and the Department of Medical Device Supervision, NMPA made specific arrangements for the key tasks in 2025.
The conference was attended by persons responsible for medical device regulation and the responsible persons of relevant divisions/offices under the medical products administrations of all provinces (autonomous regions and municipalities) and Xinjiang Production and Construction Corps, delegates from relevant departments, bureaus, and directly controlled organs of NMPA and the Health Bureau of the Logistic Support Department under the Central Military Commission, as well as heads of the China Society for Drug Regulation, the China Association for Medical Devices Industry, the Chinese Society of Biomedical Engineering, the Chinese Society for Biomaterials, and the China Association of Medical Equipment.
Source: cnpharm.com and China Pharmaceutical News
The conference noted that in 2024, work was done to steadily advance law-based regulation work, introduce documents for the comprehensive deepening of regulatory reform, make steady progress in drafting the Medical Device Administration Law, and accelerate the formulation and revision of supporting systems; work was done to achieve significant results in the reform of the review and approval system, continuously increase innovative products, launch joint research on high-end products, and steadily implement regional strategies; work was done to further standardize local registration and filing, continuously strengthen supervision and guidance, intensify information disclosure, and accelerate capability evaluations; work was done to effectively launch consolidation and enhancement actions, promptly control risks and hidden dangers, thoroughly conduct inspections in key areas, and resolutely and effectively combat illegal acts; work was done to continuously strengthen product quality supervision and inspection, efficiently conduct sampling inspections in a targeted manner, innovate and upgrade monitoring and evaluation work, yield results in market order rectification, and deepen governance of online sales; work was done to steadily improve the regulatory system’s capabilities, continuously refine the standards system, optimize categorized management on an ongoing basis, effectively advance regulatory science research, accelerate the pace of informatization, and achieve fruitful results in international exchanges. These notable results in medical device supervision and administration strongly safeguarded the quality and safety of medical devices and effectively protected the public’s health rights and interests.
The conference emphasized that currently, the systems and mechanisms for developing new quality productive forces in China’s medical device industry are accelerating to become sounder and the medical device industry is still in its “golden period of development,” therefore, the entire system should accurately grasp the new situations and requirements facing regulatory work and keep advancing medical device regulation. The year 2025 is the concluding year of the 14th Five-Year Plan and the planning year for the 15th Five-Year Plan. The conference stressed the need to earnestly implement the “Four Strictest (strictest standards, regulation, punishment, and accountability)” requirements, follow the working ideas of “highlighting politics, enhancing regulation, securing safety, promoting development, and improving people’s wellbeing,” adhere to the general principle of pursuing progress while ensuring stability, and focus on coordinating development with safety, efficiency with fairness, and regulation with service. The conference emphasized the importance of deepening medical device regulatory reform throughout the process, strengthening the bottom line of medical device safety across the board, and supporting the high-quality development of the medical device industry across the chain, to effectively ensure the safety of people in using medical devices.
According to the conference, the document, Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation of Drugs and Medical Devices to Promote the High-quality Development of the Pharmaceutical Industry, is an important document for promoting the high-level safety and high-quality development of medical devices and achieving new heights in regulatory work at present and in the coming period, and it is important to further enhance the political stance, grasp work priorities, strengthen overall coordination, and focus on implementation, to ensure that various reform measures are implemented in a strong and orderly manner.
The conference required that medical device supervision and administration work should maintain alignment between regulatory capabilities and work needs, better coordinate and allocate regulatory resources, further strengthen risk governance, and optimize the frequency, quality, and effectiveness of enterprise inspections, and the work should put time and energy in work collaboration, exploration and pilot work, and investigative research to better coordinate development and safety and elevate medical device supervision and administration to a new level.
The conference deployed five key tasks for medical device regulation in 2025: to accelerate improving legal and standards systems as led by the formulation of the Medical Device Administration Law; to accelerate the marketing of high-end innovative medical devices by centering on deepening reform of the review and approval system; to accelerate improving compliance in the medical device industry with the goal of safeguarding the safety bottom line; to accelerate building systems and capabilities adapted to industry development and safety needs with practical training as the footing; and to accelerate the pace of opening-up and cooperation as oriented by enhancing the internationalization of regulation.
Delegates from the medical products administrations of Beijing, Hebei, Shanghai, Jiangsu, Guangdong, and Chongqing exchanged their views and delivered speeches. The principal responsible persons of the Department of Medical Device Registration and the Department of Medical Device Supervision, NMPA made specific arrangements for the key tasks in 2025.
The conference was attended by persons responsible for medical device regulation and the responsible persons of relevant divisions/offices under the medical products administrations of all provinces (autonomous regions and municipalities) and Xinjiang Production and Construction Corps, delegates from relevant departments, bureaus, and directly controlled organs of NMPA and the Health Bureau of the Logistic Support Department under the Central Military Commission, as well as heads of the China Society for Drug Regulation, the China Association for Medical Devices Industry, the Chinese Society of Biomedical Engineering, the Chinese Society for Biomaterials, and the China Association of Medical Equipment.
Source: cnpharm.com and China Pharmaceutical News