China - Catalog on Medical Device Classification (Revised Edition)

China Food and Drug Administration (CFDA) has published revised Catalog on Medical Device Classification. Catalog on Medical Device Classification (Revised Edition) is a normative document combining intended purpose, structural characteristics, pattern of use, and other related factors so as to determine the risk degree of medical devices. Catalog on Medical Device Classification (Revised Edition) contains 22 subdirectories including active surgical categories, 205 first level categories of products, 1136 second level product categories and 5641 typical examples of product names. This catalog does not contain the content of Classification Catalog on 6840 Vitro Diagnostic Products (2013 Edition), medical device kit or non-medical device product.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

Final date for comments: 60 days after circulation by the WTO secretariat

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures before 20 February 2016, so that these can be taken up suitably.