摘要
该文站在监管者的角度,对体外诊断相关产品上市前的技术审评、规范检查,上市后的不良事件监测、飞行检查及再评价等全生命周期监管过程中遇到的常见问题进行了汇总分析,并提出了相应的监管建议。旨在为法规的修订与完善,监管人员实际操作层面应加强的关注点提供技术参考。
This article analyzes common problems and offers some suggestions on full life-cycle supervision and administration process of in vitro diagnostics,including premarket technical evaluations,pre-market QMS on-site inspections,postmarket adverse event surveillance,unannounced inspections and re-evaluation,from regulators’perspectives.It aims to provide technical reference for revisions on regulations,and help government administrators to figure out major points in daily regulatory practice.
作者
杨笑鹤
马琳榕
王雯
甄辉
YANG Xiaohe;MA Linrong;WANG Wen;ZHEN Hui(Zhejiang Center for Medical Device Evaluation(Zhejiang Provincial Center of Medical Device Adverse Events Monitoring and Safety Research),Hangzhou,311121;Zhejiang Center for Drug Certification&Inspection,Hangzhou,310013)
出处
《中国医疗器械杂志》
2018年第2期129-132,共4页
Chinese Journal of Medical Instrumentation
基金
浙江省科技厅重点软科学研究项目(2016C25045)
关键词
体外诊断试剂
全生命周期
常见问题
法规修订
in vitro diagnostics
full life-cycle supervision
common problems
revisions on regulations
