上海市第二类无源医疗器械立卷审查试行现状分析与改进建议

Status Analysis and Improvement Suggestions on Filing Review Trial Implementation of Shanghai’s ClassⅡPassive Medical Device Registration

通过对上海市第二类医疗器械无源产品注册立卷审查试行以来的情况进行统计,汇总分析了立卷审查阶段的共性发补问题,并给出改进建议,供注册申请人和审评人员参考,以进一步提高申报资料质量、提升审评效率。

This article collected the statistics of Shanghai’s classⅡpassive medical device registration filing review trial implementation.It summarized and analyzed the common issues in the filing review stage,and gave suggestions for registration applicants and reviewers in order to further improve the quality of application materials and improve the efficiency of review.