Jan 9, 2019

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NMPA has published draft guidance (link in Chinese) on the voluntary filing process for Device Master Files, or DMFs. Through the process, DMF owners will be able to share technical information with NMPA reviewers without disclosing this information to applicants during device registrations, according to Emergo by UL consultants in Hong Kong.

Specifics of the new DMF record filing process

Key components of NMPA’s new DMF record filing process include the following:

  • Companies may submit DMFs directly to NMPA;
  • All DMF submissions will undergo completeness reviews before acceptance by NMPA for use in follow-up device registrations;
  • All DMF documents must be signed and translated into Chinese;
  • NMPA will roll out an online platform for medical device record registration, although hard copies of DMF materials must still be submitted to the regulator;
  • NMPA will allow updates to DMF records.

Related Chinese medical device regulatory resources from Emergo by UL:

  • China NMPA medical device registration consulting
  • Chinese medical device clinical and testing requirements assessment
  • China medical device regulatory strategy report
  • Regulatory process chart: China NMPA registration and approval
  • Whitepaper: China NMPA registration requirements