CFDA Publishes New List of Medical Devices Exempt from Clinical Trial Requirements

On September 30, 2016, the China Food and Drug Administration (CFDA) has published a new list of medical devices exempt from clinical trial requirements in for approval in the country.

The new CFDA list includes 276 Class II devices and 92 Class III devices that became exempt from CFDA clinical trial requirements. The 276 Class II devices include assisted reproduction products, plastic surgery devices and interventional devices and the 92 Class III devices include blood processing and bypass equipment.

-For a complete list of class II devices exempt from CFDA clinical trial requirements, please Click here.

-For a complete list of class III devices exempt from CFDA clinical trial requirements, please Click here.

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