Approval Status and Suggestions on Supervision of Class II Innovative Medical Device.
10.3969/j.issn.1671-7104.2023.01.014
- Author:
Shimei DUAN
1
;
Zhizhen ZHONG
1
Author Information
1. Shanghai Medical Device and Cosmetics Evaluation and Verification Center, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
approval;
innovative medical device;
supervision
- MeSH:
Device Approval;
China;
Equipment and Supplies
- From:
Chinese Journal of Medical Instrumentation
2023;47(1):80-82
- CountryChina
- Language:Chinese
-
Abstract:
Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.
