Medical Device Master Files in China – clarification on use

Medical Device Master Files in China were introduced in 2021 but the NMPA has recently clarified their use for the registration of medical devices.

The National Medical Products Administration (NMPA) originally released Announcement No. 36 of 2021 on the Medical Device Master File Registration.

At that time the NMPA’s Center for Medical Device Evaluation (CMDE) established the registration platform and database of medical device master files. The CMDE publishes relevant information of master file registrations on its official website the CMDE for the convenience of public inquiry.

This recent announcement clarifies the following matters:

What is the MDMF and who is it for

The medical device master file (MDMF) is a form of technical data, which is directly submitted by its owner to the medical device regulatory authority. This technical data can then be used by an applicant for medical device product registration. The registration of the medical device master file is voluntary.

The main content of the MDMF registration mainly concerns medical device raw materials and components.

The MDMF system is used for the registration of MDMFs cited in the registration, change application, clinical trial approvals and other application items of:
- imported Class II and Class III medical devices & IVDs
- and domestic Class III medical devices & IVDs
- Drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government may, according to the actual situation, carry out the registration of MDMFs of domestic Class II medical devices with reference to this announcement.

Advantages of the MDMF

The MDMF system focuses on the scientific objectives of supervision and solves bottleneck problems in the registration and application review of medical devices by improving the efficiency of the review and approval process.

It facilitates the selection of raw materials and key components by medical device manufacturers

The information submitted in the MDMF registration is fully confidential, so the MDMF applicant can maintain independence from medical device manufacturer clients

The process

The applicant for medical device registration shall guide and assist the owner of the MDMF to establish the master file according to the relevant requirements of the medical device registration application data, and take full responsibility for the medical device it has applied for.

The owner of the medical device master file can submit the MDMF registration data through the registration platform, and obtain the master file registration number after registration.

The Center for Medical Device Evaluation (CMDE) will review the master file after the registration application of the associated medical device is filed.

When the CMDE publishes the registration information of an MDMF, it is simply the registration content of an MDMF that is made available publicly. It does not mean that the content of the MDMF has undergone technical review or that the relevant raw material or component has been used in a medical device.