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[Analysis of Changes in Medical Device Classification Concept of the New EU Regulations]
Chunqing Zhang1, Liangbin Zhou2, Yue Wang1
1National Institute for Food Drug Control, Beijing, 100050. ##Email#.
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.
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