China – Chinese Regulators Revamp Innovative Medical Device Review Process

EMERGO SUMMARY OF KEY POINTS:

  • The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program.
  • NMPA updates to the innovative device registration program take effect December 1, 2018.

The National Medical Products Administration (NMPA), China’s medical device market regulator, has developed new procedures taking effect December 1, 2018 for premarket reviews of innovative devices.

The new NMPA policy, Order 83 [2018], will replace CFDA Order 13 [2014] (links in Chinese), according to Emergo by UL sources, and includes three major changes…