[Analysis of Changes in Medical Device Classification Concept of the New EU Regulations]

Chunqing Zhang; Liangbin Zhou; Yue Wang; Li Yi; Wanjuan Yang; Shankui Rong; Jingli Li

doi:10.3969/j.issn.1671-7104.2018.03.013

[Analysis of Changes in Medical Device Classification Concept of the New EU Regulations]

Zhongguo Yi Liao Qi Xie Za Zhi. 2018 May 30;42(3):202-205. doi: 10.3969/j.issn.1671-7104.2018.03.013.

[Article in Chinese]

Authors

Chunqing Zhang¹, Liangbin Zhou², Yue Wang¹, Li Yi¹, Wanjuan Yang¹, Shankui Rong¹, Jingli Li¹

Affiliations

¹ National Institute for Food Drug Control, Beijing, 100050. ##Email#.
² Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663. ##Email#.

PMID: 29885129
DOI: 10.3969/j.issn.1671-7104.2018.03.013

Abstract

By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.

Keywords: classification management; medical devices; regulation; the European Union.

MeSH terms

Equipment and Supplies / classification*
European Union*
Government Regulation*
Industry