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

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

doi:10.3969/j.issn.1671-7104.2018.03.013

Zhang Chunqing, Zhou Liangbin, Wang Yue, Yi Li, Yang Wanjuan, Rong Shankui, Li Jingli. Analysis of Changes in Medical Device Classification Concept of the New EU Regulations[J]. Chinese Journal of Medical Instrumentation, 2018, 42(3): 202-205. DOI: 10.3969/j.issn.1671-7104.2018.03.013

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

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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.

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

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