A large amount of medical device registrations in China makes the classification process longer than it should be.

The China Food and Drugs Administration (CFDA) has introduced a new classification catalogue for Medical Devices to simplify this process. The new catalogue will be effective from the 1st of August 2018.

The new Medical Device Classification Catalog includes:

-          22 sub-catalogues for medical device and clinical features

-          Sub-catalogs for other features including 1st and 2nd product categories, intended use and so on.

-          Classification depends on use case scenarios

The new catalogue has been used as a reference by the FDA and also the EU Notified Body, there is some contrast to the old version, it also includes instructional and operational information.

Timelines:

-          All applications submitted after 1st August 2018 will apply the new rules

-          If a device meets a higher classification category, the manufacturer needs to apply for a new CFDA registration

-          If a device meets a lower classification category, the manufacturer needs to apply for a Class I notification or 6 months extension from the expiration date of the device.

Manufacturers should notice whether their devices need new registration or not and re-register them before the implementation on 1st  August 2018.