Beginning January 1, 2017, the China Food and Drug Administration (CFDA) will be accepting priority review applications for medical devices. Eligible devices include class III devices manufactured in China and class II and III imported devices. This final decision follows the CFDA’s announcement in June 2016 for new high-priority review timelines for devices that address unmet needs. In September 2016, the CFDA also released an updated list of devices deemed exempt from the local clinical trial requirement. Together, these efforts aim to improve and expedite China’s product registration system.
