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Staying On The FDA’s Right Side: Chinese Device Firms And US Compliance

This article was originally published in PharmAsia News

Executive Summary

The nuances of regulatory compliance can be daunting, especially for exporters unfamiliar with the workings of regulations and their enforcers. For Chinese medical device manufacturers, meeting regulatory requirements can be especially difficult to achieve as they face mounting pressure to maintain double-digit growth, launch new products, and beat development cycles, all while operating costs tighten.

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