上海市第二类体外诊断试剂注册申报常见问题和对策分析

Common Problems and Suggested Solutions in the Registration of Shanghai’s Class II in Vitro Diagnostic Reagent

通过对2021年6月~2022年8月上海市第二类体外诊断试剂产品注册发补内容进行统计,汇总分析了发补过程中的常见问题,并提出对策建议,供注册申请人和审评人员参考,以进一步提高体外诊断试剂注册申报资料质量,提升技术审评效率。

Based on the statistics of technical evaluations of classⅡin vitro diagnostic reagent in Shanghai from June 2021 to August 2022,this article summarized and analysed the common problems listed in the correction notifications of the technical evaluation,and then provides some relevant countermeasures or suggestions for applicants and reviewers,with a view to further improving the quality of application materials and speeding up the efficiency of review.