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.
- 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.
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