摘要
介绍了日本医疗器械上市后风险管控计划的相关法规、适用范围、指南及要求,阐述了《医疗器械上市后风险管控计划》和《上市后调查实施计划》的提交方式,分析了日本医疗器械上市后风险管控计划对我国的启示,提出了明确风险管控计划涵盖的内容,对注册人、备案人提出制定和实施风险管控计划的要求及加强医疗器械上市后监管的系统化等建议,为我国医疗器械监管提供了参考。
The related regulations,scope of application,guidelines and requirements for the post-marketing risk management and control plan for medical devices in Japan were introduced,and the ways to submit the plans for post-marketing risk management and control and for post-marketing investigation implementation were described.The implications of the post-marketing risk management and control plan for medical devices in Japan were analyzed for China.Suggestions were made to clarify the contents covered by the risk management and control plan,to make requirements for registrants and filers to formulate and implement the risk management and control plan and to strengthen the systematization of post-marketing supervision of medical devices.References were provided for the supervision of medical devices in China.
作者
苑富强
李非
YUAN Fu-qiang;LI Fei(National Institute for Food and Drug Control,Beijing 102629,China;Liaoning Medical Device Test Institute,Shenyang 110171,China)
出处
《医疗卫生装备》
CAS
2021年第11期72-75,共4页
Chinese Medical Equipment Journal
关键词
医疗器械
医疗器械监管
风险管控
风险管控计划
医疗器械上市
medical device
supervision of medical devices
risk management and control
risk management and control plan
marketing of medical devices
