The new version of the Category of Medical Device Classification is in effect, are you still using the word version?

  • 2018-08-02
On August 31, 2017, the China Food and Drug Administration (CFDA) issued the newly revised Category of Medical Device Classification which was required to take effect from August 1, 2018.

The newly revised Category of Medical Device Classification (hereinafter referred to as the new Category) has been integrated and simplified on the basis of the original 43 subcategories in the version of 2002, forming 22 new subcategories. The original 260 product categories were further divided into 206 Class I product categories and 1157 Class II product categories. The intended use and description of products were added. On the basis of the original 1008 representative product names, the number of representative product names was expanded to 6609.

Users can not only refer to the specific content of each product category step by step according to the subcategories, but also search the product keywords to locate the desired product details more quickly and accurately. In addition to the new version, the mini program, Category of Medical Device Classification, includes the 6840 Classified Subdirectory of in Vitro Diagnosis Reagent (2013), being the query system in the whole medical device classification category. Users can either view the content by category as needed or retrieve all the content by one key.

In addition, the query tool features a web version which is more powerful and used for computer users. Through direct access to the website “”, users can not only use all the functions of the mini program, but also find the required medical device information more precisely via the classification of “standard category/IVD subcategory”, “management category” and “combination of drugs and devices”. Meanwhile, users can find more information about related products in “representative product names”.