China ’ s FDA releases revised medical device classifications

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, according to China Med Device. In the update, the CFDA added more than 5,000 product name examples, bringing the total up to 6,609 from the original 1,008 devices in the 2002 catalogue, according to the report. The CFDA decreased the number of sub catalogue items from 43 to 22, but increased the number of product categories from 260 total to 206 Level I product categories and 1157 Level II product categories. Sub catalogues are now split into surgical instruments, devices with active electronics, devices with passive electronics, devices separated by clinical departments (including ophthalmic devices, dental instruments and women’s health products) and non-specific “other” devices, which include software, clinical testing devices and rehabilitation devices. The new 3 level structure also includes new key information including product descriptions and clinical indications for standardization, broader coverage of product names and a decrease in the percentage of Class III medical devices, according to the report. The changes are set to go into effect Aug. 1, 2018, and any applicants whose products were approved before that date will not be affected by the changes, according to China Med Device. After that date, all devices will be filed based on the up...
Source: Mass Device - Category: Medical Devices Authors: Tags: Regulatory/Compliance China Food & Drug Administration (CFDA) Source Type: news