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.
国家科技期刊平台
NSTL
万方数据
