Staying on the right side of the Food and Drug Administration

Jul 2016

Chinese medical device manufacturers and US regulatory compliance

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.