Status Analysis and Improvement Suggestions on Filing Review Trial Implementation of Shanghai's Class II Passive Medical Device Registration.
10.3969/j.issn.1671-7104.2022.04.018
- Author:
Xin JIANG
1
Author Information
1. Shanghai Medical Device and Cosmetics Evaluation and Verification Center, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
class II passive medical devices;
correction;
registration and filing review
- MeSH:
China;
Device Approval;
Equipment and Supplies;
Registries
- From:
Chinese Journal of Medical Instrumentation
2022;46(4):438-440
- CountryChina
- Language:Chinese
-
Abstract:
This article collected the statistics of Shanghai's class II passive 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.
