Changes to China’s Medical Device Classification May Require New Registrations

A recently published medical device classification catalog issued by the China Food and Drug Administration (CFDA) may require some device manufacturers to reregister their devices in 2018.

According to a recent posting by the Emergo Group, the CFDA’s new classification catalog incorporates 22 sub-categories of product codes, covering primary and secondary device types, intended uses and classifications. Use of these new “sub-catalog” codes will be required on all CFDA submissions and registration extensions filed as of August 1, 2018, replacing all prior classification codes for Class II and Class III devices. Until then, the current list of classification codes remains in effect.

The new classification catalog is applicable only to medical devices, and not to in-vitro diagnostic products.

Read the complete text of the CFDA’s new classification catalog is available (in Chinese) at the CFDA website.

Read the text of the Emergo Group posting on this issue.  

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