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[医疗器械标准体系的进展]

[Advances in Medical Device Standard System].

作者信息

Xu Huiwen, Wang Yue, Yang Xiaofang, Li Jingli

机构信息

National Institutes for Food and Drug Control, Beijing, 102629.

出版信息

Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Jan 30;42(1):49-52. doi: 10.3969/j.issn.1671-7104.2018.01.013.

DOI:10.3969/j.issn.1671-7104.2018.01.013
PMID:29862747
Abstract

Medical device standards provide effective technique foundation for supervision to ensure medical device safety for the people. With the optimization and upgrading of the medical device industry, the medical devices standard system including law and regulation system, organization management system, and technical management system has been advanced and developed. According to the requirements of the development of medical device industry and its standards, we put forward four working ideas, in order to improve the scientificity and applicability of medical device standards.

摘要

医疗器械标准为监管提供了有效的技术基础，以确保医疗器械造福人民。随着医疗器械行业的优化升级，包括法律法规体系、组织管理体系和技术管理体系在内的医疗器械标准体系不断推进和发展。根据医疗器械行业及其标准发展的要求，我们提出了四点工作思路，以提高医疗器械标准的科学性和适用性。

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