CFDA Announces Expedited Review Process for Innovative Devices

The China Food and Drug Administration (CFDA) announced on 7 February 2014 the implementation of a new expedited priority review and approval process for innovative medical devices, to take effect as of 1 March 2014.

The CFDA stressed that the expedited procedure would not lower existing review and approval standards, but instead would expedite the marketing of new innovative medical device technologies. The new process is also expected to promote the research and development of innovative new medical device technologies. 

In order to qualify for the new review process, a medical device must have a patent or a patent pending, and provide a significant clinical benefit.