overview

As per the Announcement no. 36 of 2021, lists requirements for voluntary submission of domestic Class III and imported Class II and III medical devices and IVDs. The announcement outlines procedures and requirements of a DMF submission and includes attachments for application forms, record filing receipt template, DMF procedures and description of matters related to DMF registration. DMF submission is a voluntary process and is not reviewed until the associated medical device application is accepted.  

Digital Certificate for dmf registration

Local DMF holders or local representatives (for overseas DMF holders) can apply for a digital certificate of DMF Registration via the CMDE’s (Center for Medical Device Evaluation) eRPS system. This digital certificate is known as a “CA Certificate”. However, it will not be necessary for those who are already certificate holders. After applying for the CA certificate, the applicants can refer to the requirements listed on the eRPS system to prepare and submit the dossier for the DMF registration.

This announcement also provides DMF registration or domestic Class II medical devices and IVDs for all provinces, autonomous regions, and municipalities under central government.

Technical Data Requirements

As a Device Master File covers technical data information required in the NMPA registration dossier, however, the DMF format may not be suitable for some specific information (e.g., IVD raw materials) in the dossier submission. The announcement attaches 6 Annexes, application forms, registration receipt, requirements, and description for DMF registration

List of Annexes attached in order no. 36

  1. Application form for registration of main file of medical device
  2. Application Form for Registration and Update of the Master File of Medical Devices
  3. Medical device master file registration receipt
  4. Information related to the registration of the master file of medical devices.
  5. Requirements for the form of registration materials for the master file of medical devices
  6. Description of matters related to medical device master file registration

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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