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Chinese Regulators Revamp Innovative Medical Device Review Process

Regulatory Updates | Medical Devices

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:

  • Innovative Device Applications 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.

Additional Chinese medical device regulatory information:

  • China NMPA medical device registration consulting
  • China medical device clinical testing assessment
  • Regulatory process chart: China NMPA approval for medical devices
  • Whitepaper: China NMPA medical device registration requirements

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