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The National Medical Device Supervision and Administration Work Conference will be held in 2025.
From January 16 to 17, 2025, the National Medical Device Supervision and Administration Work Conference was held in Shijiazhuang City, Hebei Province. The conference was guided by Xi Jinping's Thought on Socialism with Chinese Characteristics for a New Era, deeply studied and implemented the spirit of the 20th National Congress of the Communist Party of China and the second and third plenary sessions of the 20th Central Committee, implemented the requirements of the National Drug Supervision Work Conference, summarized the work of 2024, analyzed the current situation, and deployed key tasks for 2025. Xu Jinghe and Lei Ping, members of the Party Leadership Group and Deputy Directors of the National Medical Products Administration, attended the meeting and delivered speeches.
The conference pointed out that in 2024, the construction of regulatory rule of law will be steadily advanced, the comprehensive deepening of regulatory reform documents will be smoothly issued, the drafting of the Medical Device Management Law will be steadily promoted, and the revision of supporting systems will be accelerated; the effectiveness of review and approval reforms will be significant, innovative products will continue to grow, high-end products will be tackled in coordination, and regional strategies will be steadily implemented; local registration and filing will continue to be standardized, supervision and guidance will be continuously strengthened, information disclosure will be intensified, and capability evaluation will be accelerated; solid actions to consolidate and enhance will be carried out, risks and hidden dangers will be controlled in a timely manner, inspections in key areas will be conducted in depth, and illegal and irregular behaviors will be resolutely and forcefully cracked down; product quality supervision will be continuously strengthened, supervision and inspection will continue to exert force, supervision and sampling will be precise and efficient, monitoring and evaluation will be innovatively upgraded, the rectification of business order will show results, and the governance of online sales will continue to deepen; the capacity of the regulatory system will be steadily improved, the standard system will be continuously improved, classified management will be continuously optimized, regulatory scientific research will be vigorously promoted, information construction will accelerate, and international exchanges will yield fruitful results. The effectiveness of medical device supervision work has significantly ensured the quality and safety of medical devices and effectively safeguarded public health rights.
The conference emphasized that currently, the system and mechanism for the development of new productive forces in China's medical device industry are accelerating to improve, and the medical device industry is still in a "golden development period." The entire system must accurately grasp the new situation and new requirements facing regulatory work and continuously push the medical device supervision cause forward. The year 2025 is the concluding year of the 14th Five-Year Plan and the planning year of the 15th Five-Year Plan. We must earnestly implement the requirements of the "four strictest" and follow the work ideas of "political guidance, strong regulation, ensuring safety, promoting development, and benefiting people's livelihoods," adhere to the general tone of seeking progress while maintaining stability, focus on coordinating development and safety, efficiency and fairness, regulation and service, deepen the reform of medical device supervision throughout the process, build a solid safety bottom line for medical devices in all aspects, support the high-quality development of the medical device industry throughout the entire chain, and effectively ensure the safety of people's use of medical devices.
The conference believed that the "Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote the High-Quality Development of the Pharmaceutical Industry" is an important document for promoting high-level safety and high-quality development of medical devices in the current and forthcoming period, and achieving a new level of regulatory work. We must further enhance our political stance, grasp the key points of work, strengthen overall coordination, and ensure the effective and orderly advancement of various reform measures.
The conference required that the medical device supervision and management work should match the capability level with regulatory work, better coordinate and allocate regulatory resources, further strengthen risk governance, optimize the frequency and quality of enterprise inspections, and make efforts in work collaboration, pilot exploration, and research, to better coordinate development and safety, and promote the medical device supervision and management work to a new level.
The conference deployed five key tasks for the medical device regulatory work in 2025: to promote the formulation of the Medical Device Management Law as a guide, accelerate the improvement of the legal standard system; to deepen the reform of the review and approval system as the core, accelerate the pace of high-end innovative medical devices entering the market; to firmly hold the safety bottom line as the goal, accelerate the improvement of the compliance level of the medical device industry; to focus on practical training as a means, accelerate the construction of systems and capabilities that meet the needs of industry development and safety; to enhance the level of internationalization of regulation as a guide, accelerate the pace of opening up and cooperation.
The drug regulatory bureaus of provinces (municipalities) such as Beijing, Hebei, Shanghai, Jiangsu, Guangdong, and Chongqing made exchange speeches. The main responsible persons of the Medical Device Registration Department and the Medical Device Supervision Department of the National Medical Products Administration made specific arrangements for the key work in 2025.
The heads of medical device supervision work from the drug regulatory bureaus of various provinces (regions, municipalities) and the Xinjiang Production and Construction Corps, relevant departments of the National Medical Products Administration and its directly affiliated units, the Health Bureau of the Logistics Support Department of the Central Military Commission, and leaders from the China Drug Supervision and Administration Research Association, China Medical Device Industry Association, China Biomedical Engineering Society, China Biomaterials Society, and China Medical Equipment Association attended the meeting.
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