摘要
该文站在技术审评的角度,对近五年浙江省内注册申报的临床化学体外诊断试剂(盒)的发补内容进行统计,并对共性问题进行汇总分析,结合浙江省注册专员公益培训中遇到的相对人常见问题,提出了相应的建议。旨在为注册申报人员合理高效准备注册申报资料,以及审评人员应加强的关注点提供技术参考。
From the perspective of technical review,this paper made statistics on the supplement contents of in vitro diagnostic reagent(kit)for clinical chemistry registered in Zhejiang province in the past five years,summarized and analyzed the common problems,and put forward corresponding suggestions based on the common problems encountered in the public welfare training of registered specialists in Zhejiang province.The aim is to provide technical reference for registrars to prepare registration documents reasonably and efficiently and for review staffs to strengthen their points of focus.
作者
杨笑鹤
董沁芳
朱文武
甄辉
YANG Xiaohe;DONG Qinfang;ZHU Wenwu;ZHEN Hui(Zhejiang Center for Medical Device Evaluation(Zhejiang Provincial Center of Medical Device Adverse Events Monitoring and Safety Research),Hangzhou,311121)
出处
《中国医疗器械杂志》
2020年第6期537-540,557,共5页
Chinese Journal of Medical Instrumentation
基金
浙江省食品药品监管系统科技计划项目(YQ2018005)。
关键词
临床化学体外诊断试剂(盒)
注册申报
常见问题
关注点
in vitro diagnostic reagent(kit)for clinical chemistry
registration and declaration
common problems
points of focus
