Li Ying, Chu Zhaowei, Fan Yubo
School of Biological Science and Medical Engineering, Beihang University, Beijing, 100191.
National Research Centre for Rehabilitation Technical Aids, Beijing, 100176.
Zhongguo Yi Liao Qi Xie Za Zhi. 2017 May 30;41(3):220-223. doi: 10.3969/j.issn.1671-7104.2017.03.017.
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.
自2014年第650号令发布以来，中国国家食品药品监督管理总局（CFDA）组织专业人员在原有医疗器械监管法规体系的基础上密集制定和修订法规。截至目前，中国医疗器械监管新法规体系已基本形成，对整个医疗器械行业具有深远的积极影响。本文从制造商的角度分析了医疗器械监管新法规体系要求的变化，并试图提供一些适应这些要求的简单建议。
