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China: CFDA proposes revised classification of medical devices

2016/10/05

Proposed changes to the system include the addition of information beyond the name and category of the product. Specifically, CFDA plans to add descriptions of products and their intended uses. The regulator is also aiming to make the classification system more capable of incorporating novel types of medical device and iron out some of the technical shortcomings of the current directory.

CFDA detailed its revised classification system and the thinking behind its changes in an extensive document and accompanying annexes. CFDA has given the industry until 25 November to comment on the draft classification system.

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