中国食品药品监管Issue(3)：42-51,10.DOI:10.3969/j.issn.1673-5390.2026.03.004
优化人工智能医疗器械全生命周期监管:国际经验与中国路径
Optimizing the Full Lifecycle Regulation of Artificial Intelligence Medical Devices:International Experience and China's Approach
摘要
Abstract
Objective:This study aims to examine international regulatory experience in artificial-intelligence(AI)medical devices,assess the current status and limitations of China's regulatory framework,and propose actionable pathways toward a scientific,flexible,and transparent lifecycle regulatory system.Methods:A comparative research approach was adopted,selecting the United States,the European Union,and Japan as representative cases.Their regulatory models were reviewed across four dimensions:approval pathways,prospective algorithm change mechanisms,risk classification,and post-market surveillance,and analyzed in conjunction with China's recent medical device policies and practices.Results:The United States is characterized by flexible review mechanisms and strong support for innovation;the European Union emphasizes risk prevention and regulatory transparency;and Japan,while maintaining a prudent regulatory foundation,has introduced prospective change management and data-driven post-market monitoring.China has established an initial regulatory framework supported by guidance documents,standards,and technical review requirements,and has made progress in the application of real-world data/evidence(RWD/RWE).Nonetheless,gaps remain in developing prospective regulatory pathways for algorithm updates,refining risk classification and technical specifications,and strengthening interdepartmental coordination.Conclusion:China should draw on international experience to further refine its risk classification system,establish pre-review and dynamic management mechanisms for prospective algorithm changes,promote the systematic use of real-world data,strengthen cross-sector collaboration,and pilot regulatory sandbox initiatives.In particular,it is necessary to build a full lifecycle regulatory framework centered on a closed-loop model of"approval–update–use–monitoring",thereby improving iterative efficiency while ensuring safety and effectiveness and forming replicable and scalable regulatory practice.关键词
人工智能/医疗器械/全生命周期监管/国际比较/政策建议Key words
artificial intelligence/medical devices/full lifecycle regulation/international comparison/policy recommendations分类
医药卫生引用本文复制引用
李屹玲,赵琪,魏旗鹏,胡琳琳..优化人工智能医疗器械全生命周期监管:国际经验与中国路径[J].中国食品药品监管,2026,(3):42-51,10.基金项目
中国医学科学院医学与健康科技创新工程(2021-I2M-1-046) （2021-I2M-1-046）
