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
赵一飞 1赵燕 1刘斌 2郑立佳 1翟伟 2李栋 1宋雅娜 1闫炜 2董放1
作者信息
- 1. 国家药品监督管理局药品评价中心 医疗器械监测和评价部 北京 100076
- 2. 北京市药品不良反应监测中心 北京 101117
- 折叠
摘要
无源植入类医疗器械是不依靠电能或其他能源、借助外科手术器械全部或部分进入人体或自然腔道中的一类医疗器械.加强无源植入类医疗器械上市后的风险评价工作,对于全面提升医疗器械全生命周期监管水平具有十分重要的意义.国家药品监督管理局药品评价中心组织相关专家组成专家组,进行讨论指导后最终形成"无源植入类医疗器械安全性评价"专家共识,通过对国内外医疗器械不良事件监测法规体系及案例进行对比分析,结合我国医疗器械不良事件监测现状,将无源植入类医疗器械的上市后安全性评价分为工作体系和技术指导原则,为开展无源植入类医疗器械上市后安全性评价提供参考依据,促进上市后的医疗器械安全性评价工作规范化.
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引用本文复制引用
基金项目
国家重点研发计划(2021YFC2009100)
国家重点研发计划(2021YFC2009104)
中国药品监管科学行动计划重点项目(第二批)([2021]37-10)
出版年
2024
国家科技期刊平台
NSTL
万方数据