CMC


CFDA presents new classification


The 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 catalog for Medical Device to simplify this process. The new catalog will be effective from the 1st of August 2018.

The new Medical Device Classification Catalog includes:

-          22 sub-catalogs for medical device and clinical features

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

-          Classification are depend on use case scenarios

The new catalog have used as reference the FDA and also the EU Notified Body, there are some contrast to the old version, it also includes instructional and operational information.

Timelines:

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

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

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

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