In early September 2017, the China Food and Drug Administration (CFDA) released plans to implement a new Catalog of Medical Devices starting on August 1, 2018. The current classification directory was established in 2002 but has been under revision since July 2015 due to lack of details and outdated regulations.
The revised catalog will have 22 sub-directories, reduced from the original 43 categories. The sub-directories are based on characteristics for technical, professional, and clinical use. Each sub-directory consists of the following:
- Product category
- Secondary product category
- Product description
- Intended use
- Product name example
- Management category
The new catalog will significantly affect medical device registrations and renewals.
After implementation of the new classification directory, devices that do not fall into any of the 22 sub-directories must go through a formal classification process prior to registration.