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Submissions To China's Fast-Track System For Innovative Device Approval Swell

This article was originally published in Clinica

Executive Summary

The number of applications going through China’s fast-track regulatory process for evaluating innovative medical devices is growing at a steady pace with 46 products admitted for evaluation so far. Of these 17 were submitted in 2014 (of which six have been approved) and 29 in 2015 (of which two have been approved). The fast track route was launched by the China Food and Drug Administration on March 1, 2014.

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