中国医学装备2024，Vol.21Issue(4)：1-6,6.DOI:10.3969/j.issn.1672-8270.2024.04.001
无源植入类医疗器械上市后安全性评价专家共识
Expert consensus on post-market safety reevaluation of passive implantable medical devices
摘要
Abstract
Passive implantable medical device is one type of medical device that does not rely on electricity or other energy sources,but utilize surgical procedures to fully or partially enter the human body or natural cavity.Strengthening the risk assessment of passive implantable medical devices after they enter market is of great significance for comprehensively improving the regulatory level of the whole lifecycle of medical devices.The Center for Drug Reevaluation of the National Medical Products Administration organized a group of relevant experts to finally form an expert consensus about"safety performance reevaluation of passive implantable medical devices"after discussion and guidance.Through comparative analysis for regulatory systems and cases of adverse event monitoring of domestic and foreign medical device,and combined with the current situation of adverse event monitoring of medical device in China,the safety reevaluation of passive implantable medical devices after they enter market are divided into work system and technical guidance principle,which can provide reference basis for conducting safety reevaluation of passive implantable medical devices after they enter market,and promote the standardization of safety reevaluation of medical devices after they enter market.关键词
医疗器械/安全性/评价/监测Key words
Medical device/Safety/Reevaluation/Surveillance分类
医药卫生引用本文复制引用
赵一飞,赵燕,刘斌,郑立佳,翟伟,李栋,宋雅娜,闫炜,董放..无源植入类医疗器械上市后安全性评价专家共识[J].中国医学装备,2024,21(4):1-6,6.基金项目
国家重点研发计划(2021YFC2009100、2021YFC2009104) （2021YFC2009100、2021YFC2009104）
中国药品监管科学行动计划第二批重点项目([2021]37-10) National Key research and development Plan(2021YFC2009100,2021YFC2009104) （[2021]37-10）
The Second Batch of Key Projects of the Scientific Action Plan for Drug Regulation in China([2021]37-10) （[2021]37-10）
