Apr 6, 2021

China’s National Medical Products Administration (NMPA) has published Announcement No. 36 of 2021 (link in Chinese), which outlines the requirements for the voluntary record filing of a Device Master File (DMF) for domestic Class III and imported Class II and III medical devices (including IVD reagents). The contents of this announcement became effective immediately upon publication. The NMPA initially released a draft guidance document concerning DMF record filing in early 2019.

The DMF record filing procedure mainly concerns raw material supplier documentation and is intended to avoid the repeated submission and review of this technical data. The announcement describes the basic procedure and requirements for a DMF submission. Attachments to the announcement include the application forms, a record filing receipt template, and other information pertaining to the DMF record filing procedure. The Center for Medical Device Evaluation (CMDE) will issue a DMF registration number following the submission process.

Accompanying guidance document sheds light on DMF record filing requirements

The NMPA also published a guidance document (link in Chinese) providing commentary on the announcement and further explaining the requirements for DMF record filing. Notably, the regulatory authority will only review the DMF when an associated medical device application is submitted. The medical device applicant must obtain a Letter of Authorization from the DMF owner to reference the DMF for the medical device registration application.

CMDE announcement addresses electronic DMF submissions using eRPS system

Additionally, the CMDE issued its Announcement No. 2 of 2021 (link in Chinese) to set up a platform for DMF submissions, comprising a module of the eRPS system for electronic medical device regulatory submissions. The DMF must be submitted by a local Chinese company with access to the eRPS system, using a Certificate Authority (CA). Included as attachments to the announcement are 1) a guide to applying for and managing a CA, and 2) an "Electronic Catalog for Master File Registration," which outlines the required format and content of the DMF.

Related Chinese medical device regulatory resources from Emergo by UL:

  • China NMPA medical device registration consulting
  • Chinese medical device clinical and testing requirements assessment
  • Whitepaper: China NMPA registration requirements
  • Webinar: Medical device registration in China

Author

  • Timothy Herr

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