Administrative reform thinking on the regulations on the supervision and administration of medical devices.
- Author:
Wei YUE
1
Author Information
1. Shanghai Food and Drug Administration. yuewei@smda.gov.cn
- Publication Type:Journal Article
- MeSH:
Device Approval;
Equipment and Supplies;
standards;
Government Regulation
- From:
Chinese Journal of Medical Instrumentation
2014;38(5):357-360
- CountryChina
- Language:Chinese
-
Abstract:
This paper learned and interpreted the regulations on the supervision and administration of medical devices, carded the thoughts of administrative reform, then put forward the "ten principles", including full supervision, classification supervision, risk classification, safety-effective-save, to encourage innovation, simplified license, scientific-standard, sincerity & self-discipline, clear responsibility, severe punishment, and discussed these priciples.
