China – Changes to the Classification of Medical Devices

The China Food and Drug Administration (CFDA) has recently announced its new “Medical Device Classification Catalogue”. The revised medical device classification directory has significant implications for medical devices registrations and renewals. The new catalogue was announced with a draft release on August 31, 2017. After a feedback period, the final catalogue will go into effect in less than a year – on August 1, 2018.

The updated catalogue downgrades the risk level of 40 types of devices, moving them from either Class III to Class II or from Class II to Class I. It also upgrades certain devices to Class III.

Further, the update drastically increases the number of product name examples from 1,008 to 6,609.

Applicants whose CFDA certificates are approved before August 1, 2018 will not be affected by the new classification. After August 1, 2018, all registrations and reviews shall correspond to the new catalogue.