Chinese regulators take steps to ease medical device registration

Stewart Eisenhart

THE China Food and Drug Administration (CFDA) has announced steps in recent weeks to improve its medical device classification process and ease the path to market for innovative devices.

Electronic validation for CFDA device classifications First, the CFDA is establishing an online system for medical device manufacturers to request regulatory validation of their product classification at the provincial or central level. Previously, manufacturers unsure of how to classify their devices under the Chinese system would have to submit classification requests in writing.

Exemptions from CCC Mark requirements Second, Chinese regulators have exempted eight categories of medical devices from requisite China Compulsory Certification (CCC) Mark certification. The CCC Mark applies to a wide range of automotive, wireless and other consumer products as well as some medical devices.

The following types of medical devices are no longer required to obtain CCC Mark certification:

New review process for innovative devices Finally, the CFDA has released a draft proposal to establish a special approval process for innovative medical devices in China.

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