第二类临床化学体外诊断试剂(盒)注册申报常见问题分析

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

      • 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。

         

        Abstract: 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.

         

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