Advances in Medical Device Standard System.
10.3969/j.issn.1671-7104.2018.01.013
- VernacularTitle:医疗器械标准体系进展
- Author:
Huiwen XU
1
;
Yue WANG
1
;
Xiaofang YANG
1
;
Jingli LI
1
Author Information
1. National Institutes for Food and Drug Control, Beijing, 102629.
- Publication Type:Journal Article
- Keywords:
medical device;
safety and effectivity;
standardization
- MeSH:
Equipment Safety;
Equipment and Supplies;
standards;
Industry;
Reference Standards
- From:
Chinese Journal of Medical Instrumentation
2018;42(1):49-52
- CountryChina
- Language:Chinese
-
Abstract:
Medical device standards provide effective technique foundation for supervision to ensure medical device safety for the people. With the optimization and upgrading of the medical device industry, the medical devices standard system including law and regulation system, organization management system, and technical management system has been advanced and developed. According to the requirements of the development of medical device industry and its standards, we put forward four working ideas, in order to improve the scientificity and applicability of medical device standards.
