Medical Devices

Global Regulatory Partners

New Program for the Review of Innovative Medical Devices in China

The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program that will take effect December 1, 2018. The new NMPA policy, Order 83 [2018] includes three major changes: Applications for Innovative Devices must be submitted to NMPA within five years of patent publications; Application review timeframes will …

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CFDA Announced Major Changes to Chinese Medical Device Regulations in favor of Foreign Manufacturers

China Food and Drug Administration (CFDA) proposed major changes to medical device regulatory requirements by amending Order No. 650. The timeframe for the implementation of such changes has not been announced by CFDA yet, but foreign medical manufacturers are welcoming the new changes as they will address the major issues they are facing while registering …

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