[Analysis of Class II Common Problems in the Registration of Diagnostic Reagent (Kit) for Clinical Chemistry].

作者信息

Yang Xiaohe, Dong Qinfang, Zhu Wenwu, Zhen Hui

机构信息

Zhejiang Center for Medical Device Evaluation(Zhejiang Provincial Center of Medical Device Adverse Events Monitoring and Safety Research), Hangzhou, 311121.

出版信息

Zhongguo Yi Liao Qi Xie Za Zhi. 2020 Dec 8;44(6):537-540. doi: 10.3969/j.issn.1671-7104.2020.06.014.

DOI:10.3969/j.issn.1671-7104.2020.06.014

PMID:33314864

Abstract

From the perspective of technical review, this paper made statistics on the supplement contents of 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.

摘要