2024年度国家医疗器械不良事件监测报告发布

Core Viewpoint - The 2024 Annual Report on Adverse Events Monitoring of Medical Devices indicates a significant increase in reported adverse events, reflecting improved regulatory oversight and risk management capabilities in China's medical device sector [1][2]. Group 1: Report Statistics - A total of 946,200 adverse event reports were received in 2024, representing a 9.11% increase from the previous year [2]. - The average number of adverse event reports per million population reached 671, also a 9.11% increase year-on-year [2]. - The majority of reports came from usage units, accounting for 849,600 reports (89.79%), followed by business enterprises with 67,200 reports (7.11%) and registrants with 29,000 reports (3.06%) [2]. Group 2: Classification of Medical Devices - Reports related to Class III medical devices totaled 379,200 (40.08%), Class II devices accounted for 482,900 (51.04%), and Class I devices made up 69,900 (7.39%) [3]. - The top five categories of reported adverse events included infusion, nursing and protective devices, medical examination and monitoring devices, clinical testing devices, and respiratory, anesthesia, and emergency devices [3]. Group 3: Monitoring and Evaluation Enhancements - The National Center for Adverse Drug Reaction Monitoring has improved its risk signal coordination mechanism, ensuring timely detection and effective management of product risks [4]. - In 2024, 12 issues of the "Medical Device Alert Bulletin" were published, summarizing 78 safety information items from international regulatory agencies, aiding in domestic safety evaluations [4]. Group 4: Collaborative Efforts and Standards Development - The report highlights advancements in the collaborative governance mechanism among regulatory departments, monitoring institutions, registrants, and medical institutions, enhancing the medical device vigilance system [5]. - The development of new technical documents, including the "Quality Management Specification for Medical Device Vigilance (Trial Version)," has been initiated, contributing to the establishment of a robust vigilance system [5]. Group 5: International Cooperation - The National Center for Adverse Drug Reaction Monitoring actively participated in international forums and information exchange initiatives, promoting global cooperation in medical device adverse event monitoring [6].