China – NMPA publishes guidelines for Device Master File (DMF) submissions

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 The NMPA initially released a draft guidance document concerning DMF record filing in early 2019.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…