China’s FDA releases revised medical device classifications
08-Sep-17, Mass Device
Late last month, the Chinese Food and Drug Administration announced a number of changes to medical device classifications, revising criteria and categories and reducing the risk level of 40 different categories of products.
Image: Mass Device
In the update, the CFDA added more than 5,000 product name examples to the original 1,008 devices in the 2002 catalogue. The CFDA also increased the number of product categories from 260 total to 206 Level I product categories and 1,157 Level II product categories.