China | Medical Devices
EMERGO BY UL SUMMARY OF KEY POINTS:
- Chinese regulators are launching a record filing process for medical device master files (DMFs).
- DMFs are used by NMPA reviewers and Chinese market applicants during device registrations.
- The new process will be voluntary.
The Chinese National Medical Products Administration (NMPA) plans to establish a formal record filing process for Device Master Files for use in medical device registrations.
NMPA has published draft...
Source | Stewart Eisenhart
Jan 9, 2019