Guidelines on medical devices vigilance system of European Commission & its enlightenment to China.
- Author:
Han TANG
1
,
2
,
3
;
Chang-li LINGHU
;
Yue YANG
Author Information
1. School of Business and Administration, Shenyang Pharmaceutical University, Shenyang,
2. tanghan_1986@
3. com
- Publication Type:Journal Article
- MeSH:
China;
Equipment Safety;
methods;
standards;
European Union;
Guidelines as Topic;
Product Surveillance, Postmarketing;
standards
- From:
Chinese Journal of Medical Instrumentation
2009;33(3):212-214
- CountryChina
- Language:Chinese
-
Abstract:
This paper introduces the guidelines on medical devices vigilance system of European Commission and the duty of parties involved. It provides reference for establishing medical devices vigilance system and strengthening regulation of medical devices in our country.