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 increase from 40 working days to 60 working days;
  • An innovative device registration submission must be received within five years of NMPA’s confirmation that the product qualifies as an innovative device and is eligible for the special registration review route.
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