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医疗器械上市后主动监测
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国家药监局:支持医疗器械注册人开展上市后循证研究
news flash· 2025-07-03 10:12
Core Viewpoint - The National Medical Products Administration (NMPA) is implementing measures to optimize the lifecycle regulation and support the innovative development of high-end medical devices [1] Group 1: Regulatory Measures - The NMPA emphasizes the management of the usage period for high-end active medical devices [1] - Medical institutions are urged to conduct regular inspections and maintenance of surgical robots, rehabilitation robots, and high-end medical imaging equipment to ensure clinical quality [1] - The NMPA supports medical device registrants in conducting post-market evidence-based research [1] Group 2: Incident Reporting and Monitoring - The NMPA is detailing the types of adverse events related to high-end medical imaging devices and artificial intelligence medical devices, aiming to improve the quality of adverse event reporting [1] - The NMPA continues to promote the Global Harmonization Working Party (GHWP) to actively monitor new projects, focusing on high-risk cardiovascular implantable medical devices [1] - The NMPA is exploring a basic framework for post-market active monitoring of medical devices and methods for database construction [1] Group 3: Safety and Reliability Enhancement - Registrants are guided to proactively conduct post-market evaluations to enhance the safety and reliability of their products [1] - Local authorities are advised to strengthen the construction of inspection and monitoring teams for high-end medical devices, improving their inspection and monitoring capabilities [1]