[借鉴欧盟新医疗器械法规引入第三方评审制度的建议]

[The Suggestion of Introducing the 3rd Party Review System by Reference of EU New Medical Device Regulations].

作者信息

Li Ying, Fan Yubo

机构信息

School of Biological Science and Medical Engineering, Beihang University, Beijing, 100191.

National Research Center for Rehabilitation Technical Aids, Beijing, 100176.

出版信息

Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Nov 30;41(6):440-442. doi: 10.3969/j.issn.1671-7104.2017.06.013.

DOI:10.3969/j.issn.1671-7104.2017.06.013

PMID:29862706

Abstract

In order to improve the efficiency and quality of medical device review, EU adopts the third party organization-Notify Body (NB) to review the medical device. EU promulgated and implemented new Medical Device Regulation (MDR) on May, 2017, claimed more severe and detailed requirements to the third party review organizations. This paper tries to provide suggestions on introducing medical device the third party review system in China by researching the new requirements of the NB in MDR and taking consideration of China current medical device technical review situation.

摘要

为提高医疗器械审评效率与质量，欧盟采用第三方组织——公告机构（NB）对医疗器械进行审评。欧盟于2017年5月颁布并实施了新的《医疗器械法规》（MDR），对第三方审评组织提出了更严格、更详细的要求。本文通过研究MDR中公告机构的新要求，并结合中国当前医疗器械技术审评情况，尝试为在中国引入医疗器械第三方审评制度提供建议。