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.
- 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: