Research on the Management System of Medical Device Recognized Consensus Standards in USA.
10.3969/j.issn.1671-7104.2018.02.011
- Author:
Jia ZHENG
1
;
Li YI
1
;
Jingli LI
1
Author Information
1. Institute for Medical Device Standardization Administration, National Institutes for Food and Drug Control, Beijing, 102629.
- Publication Type:Journal Article
- Keywords:
USA;
consensus standards;
medical device
- MeSH:
China;
Consensus;
Device Approval;
Equipment and Supplies;
standards;
Reference Standards;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2018;42(2):119-121
- CountryChina
- Language:Chinese
-
Abstract:
This paper gives a brief introduction on the development of recognized consensus standards, the recognition working procedure and the overview of medical devices recognized consensus standards in USA, and analyzes the experience of the recognition management system in USA, aiming at providing a reference for the improvement of the medical device standard management system in China.
