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Published on: June 27, 2014
[Design and Consideration on the Revision of China Medical Device Classifcation Directory]
Jingli Li1, Jia Zheng1, Chunqing Zhang1
1National Institutes for Food and Drug Control, Institute for Medical Device Standardization Administration, Beijing, 100050.
Abstract:
The new version of Medical Device Classification Directory(revised Draft) has opened to the public comments. This paper briefly introduces the classification of medical device in China and the historical development of the directory, and focuses on the analysis of the main changes in the new version of the directory to help the supervision department, manufactures, and related organizations better understand and use the new directory.
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