Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 12 February 2014 | By Louise Zornoza
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.
Tags: Expedited Approval Pathway, Expedited Review, Priority Review, medical device