China: Clarification of Medical Device Master File in China

ARQon
Mar 29, 2023
2 min read

The National Medical Products Administration (NMPA) of China has introduced Medical Device Master File System (MDMF) in 2021 with immediate effect through Announcement No. 36 of 2021. The main intention of MDMF is to protect the rights of every person involved and only the authorized owner may be supporting the NMPA’s device registration.

The MDMF may assist in the process of registration of local and imported medical devices, renewal registration, clinical trials and licensing changes. All the database for MDMF and the registration platform is governed under the Centre for Medical Device Evaluation (CMDE) of NMPA.

Further, on January 2023 CMDE released an announcement on clarification of the medical device master file. The clarification has a detailed explanation of the purpose, advantages and process of registration of MDMF.

Purpose of Medical Device Master File

Medical Device Master File is the information of technical data sent by the owner to the medical device regulatory body and only the authorized representative has the rights to the technical data.

Medical Device Master File System will be used for the registration, renewal application, clinical trial approval of local medical devices (Class III) and in vitro diagnosis, import medical devices (Class II & III) and in vitro diagnosis and drug administrations.

The Process of Registration for Medical Device Master File

The medical device applicants may request the MDMF owner to set up the master file based on the requirements of registration application data.
The owner may proceed with the registration and receive the registration number.
The master file will be reviewed by CMDE after registration.
Once the review is successful, CMDE will publish the MDMF registration information and information will be available to the public.