2026 National Conference on Medical Device Supervision and Administration Held

From February 4 to 5, the 2026 National Conference on Medical Device Supervision and Administration was held in Shenyang. Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, the conference fully implemented the guiding principles of the 20th CPC National Congress, the plenary sessions of the 20th CPC Central Committee, and the Central Economic Work Conference, as well as the requirements of the National Drug Supervision and Administration Work Conference. It reviewed the work in 2025 and during the 14th Five-Year Plan period, analyzed the current situation, and made arrangements for key tasks in 2026. Lei Ping, member of the Party Leadership Group and Deputy Commissioner of the National Medical Products Administration, delivered the work report, while Xu Jinghe, member of the Party Leadership Group and Deputy Commissioner of the National Medical Products Administration, made the concluding remarks.

The conference noted that in 2025, the entire regulatory system earnestly implemented the major decisions and deployments of the CPC Central Committee and the State Council, and fully carried out the *Opinions of the General Office of the State Council on Deepening the Reform of Drug and Medical Device Regulation to Promote the High-Quality Development of the Pharmaceutical Industry*. Reform of the review and approval system continued to advance in depth, support for innovation was further strengthened, clinical needs were served with greater precision, and coordinated efforts were made in key areas. Registration and filing work became more standardized, review and approval became more efficient, and capacity assessment progressed steadily. Post-market supervision continued to intensify, with stronger compliance control in production, dynamic inspections in distribution and use, and continuous improvements in inspection and testing. Risks and hidden problems in key areas were continuously addressed, risk consultation was further deepened, governance of online sales risks achieved visible results, and enforcement against violations was further strengthened. The regulatory system also advanced steadily, with notable progress in rule of law, regulatory science, workforce capacity, and smart regulation.

During the 14th Five-Year Plan period, medical device regulation achieved remarkable results. The legal and regulatory system continued to improve, quality and safety risks were effectively controlled, industrial innovation became increasingly dynamic, regulatory foundations were further strengthened, and international exchanges and cooperation deepened. China’s medical device regulation achieved historic progress and leapfrog development, with both industrial innovation and product quality significantly improved, bringing a stronger sense of benefit to the public.

The conference emphasized that medical devices are closely related to people’s lives, safety, and health. The entire regulatory system must align with the new requirements of the CPC Central Committee and the State Council, further strengthen political awareness, and promote reform and innovation. It must continue to standardize regulatory order, promote a more standardized, regulated, and transparent regulatory system, and strengthen full-lifecycle risk governance based on regulatory responsibilities. It must continue to stimulate innovation, build a collaborative innovation ecosystem, and strongly promote high-quality industrial development. It must also strengthen workforce capacity and build a professional, specialized, and high-quality regulatory team, ensuring both development and safety through highly effective regulation.

The conference stated that 2026 marks the first year of the 15th Five-Year Plan. Medical device regulation in 2026 should be guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, follow the “four strictest” requirements, and fully implement the arrangements of the National Drug Supervision and Administration Work Conference. In line with the working approach of “upholding political principles, strengthening regulation, ensuring safety, promoting development, and benefiting people’s livelihoods,” efforts should be made to pursue progress while maintaining stability, improve quality and efficiency, and coordinate development and safety, efficiency and fairness, vitality and order, as well as regulation and service. Highly effective regulation should be used to ensure high-level safety of medical devices, promote high-quality development of the medical device industry, improve people’s quality of life, and contribute to the building of a Healthy China and a strong medical device manufacturing nation.

The conference set out six key tasks for medical device regulation in 2026. First, jointly advance the preparation of the 15th Five-Year Plan, systematically plan work arrangements, and scientifically set development goals. Second, build a more complete system of laws, regulations, rules, and standards by actively advancing legislation and continuously improving institutional design. Third, provide targeted support for the development of innovative medical devices, continue to release policy benefits, and focus on breakthroughs in key areas. Fourth, improve the quality and efficiency of medical device registration and filing, deepen standardized governance, and maintain consistent regulatory standards. Fifth, comprehensively manage safety risks, improve the effectiveness of risk consultation, strengthen problem-oriented supervision, and impose strict penalties on violations. Sixth, comprehensively enhance professional regulatory capacity, deepen international exchanges and cooperation, and actively build a new pattern of co-governance.

At the conference, medical products administrations from Liaoning, Beijing, Shanghai, Jiangsu, Zhejiang, Fujian, Guangdong, and Chongqing shared their experiences. The heads of the Department of Medical Device Registration and the Department of Medical Device Supervision of the National Medical Products Administration made specific arrangements for key work in 2026.

Officials responsible for medical device supervision from the medical products administrations of all provinces, autonomous regions, municipalities, and the Xinjiang Production and Construction Corps, as well as relevant department heads, attended the conference. Representatives from the Health Bureau of the Logistic Support Department of the Central Military Commission, relevant departments and affiliated institutions of the National Medical Products Administration, 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 also attended.