Common Problems and Improvement Suggestions for the Special Review Application of Shanghai's Class Ⅱ Innovative Medical Device
10.3969/j.issn.1671-7104.230219
- VernacularTitle:上海市第二类创新医疗器械特别审查申请常见问题和改进建议
- Author:
Qiong XIE
1
Author Information
1. 上海市医疗器械化妆品审评核查中心,上海市,200020
- Keywords:
Class Ⅱ innovative medical device;
review;
common problems
- From:
Chinese Journal of Medical Instrumentation
2024;48(1):85-87
- CountryChina
- Language:Chinese
-
Abstract:
This study conducted statistics on the special review applications for Class Ⅱ innovative medical devices in Shanghai from April 2020 to April 2023.It summarized and analyzed common problems in the innovation review application stage,and gave suggestions for applicants and reviewers in order to further improve the quality of innovation application and improve the pass rate of innovation applications.
