Simple Suggestion of Adapting Requirements of Medical Devices New Supervision Regulation System for Medical Device Manufacturers
10.3969/j.issn.1671-7104.2017.03.017
- VernacularTitle:浅谈我国医疗器械监管新法规体系下医疗器械生产企业应对建议
- Author:
Ying LI
1
;
Zhaowei CHU
;
Yubo FAN
Author Information
1. 北京航空航天大学生物与医学工程学院,北京市,100191
- Keywords:
medical device;
new regulation;
manufacture;
suggestion
- From:
Chinese Journal of Medical Instrumentation
2017;41(3):220-223,234
- CountryChina
- Language:Chinese
-
Abstract:
Since the releasing of Order 650 in 2014, China Food and Drug Administration (CFDA) organized professionals to intensively formulate and revise regulations based on the original medical device supervision regulations system. Up to now, China medical device supervision new regulation system has been formed basically and has profound active implications on the whole medical device industry. The article analyzed the change of requirements of medical device supervision new regulation system from manufacture's point of view and tried to provide some simple suggestions of adapting them.
