CFDA Establishes Priority Review For Innovative Medical Devices

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by Richard Daverman, PhD

March 17, 2014 -- To speed up approval of innovative medical devices, the CFDA has set up a special office at the Center for Medical Device Evaluation. The division will take 60 days to decide whether a specific device qualifies as innovative. If it does, the same group will supervise the approval process under priority procedures. Both foreign and domestic companies are eligible for the program.Although the new rules do not dictate a maximum length for CFDA prioritized review, the process is expected to shorten time-to-decision. More details....

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