China medical device master filing (MDMF) was introduced for implementation (No.36-2021) by the National Medical Products Administration (NMPA) to protect production and raw material confidential information from being disclosed to any third parties during the NMPA registration process of end products.
In this blog post, we will share an overview of the MDMF application scope and process, the importance of safeguarding confidential information and responsibilities of MDMF owners and medical device registration applicants.
Understanding MDMFs
MDMFs in China contain detailed technical and manufacturing information about medical devices, including information about the materials used during manufacturing processes, quality control procedures, and throughout the production lifecycle. These files are submitted to the NMPA as part of the registration process for medical devices.
Scope
On January 18, 2023, the Center for Medical Device Evaluation (CMDE) announced clarifications on the usage of the MDMF. The application for MDMF is voluntary and primarily focused on safeguarding the information of medical device raw materials and components. MDMF applies to imported Class II and Class III medical devices, in vitro diagnostics (IVDs), as well as domestic Class III medical devices and IVDs. Additionally, drug administrations in various regions in China may adopt MDMF as well for domestic Class II medical devices.
MDMF application process
- The MDMF owner submits the technical data via the online platform.
- Center for Medical Device Evaluation (CMDE) will review the application and the associated master file.
- The master file registration number can be obtained upon completion of filing, and the respective MDMF listing will be published online by the CMDE for public reference.
Advantage of the MDMF system
- Efficiency: It streamlines the review and approval process, addressing bottlenecks in medical device registration and application reviews.
- Material Selection: Medical device manufacturers can make informed decisions about raw materials and key components, enhancing product quality.
- Confidentiality: Information submitted for MDMF remains fully confidential, ensuring the independence of MDMF owners from their medical device manufacturing clients.
Roles and responsibilities
MDMF changes how certain application data is submitted whereas the medical device registration applicant still holds full responsibility for the data submitted in terms of product safety and quality. The applicant should follow through the master file creation process and provide guidance and support to the MDMF owners as required. The roles and obligations of MDMF owners can be determined through contractual agreements with the applicant. However, the regulatory entity and responsible party for medical devices remain to be the applicant and not the MDMF owner.
Domestic owners can apply for MDMF themselves in China, however, overseas owners (including those from Hong Kong, Macau, and Taiwan) must appoint a domestic agency to apply for MDMF. All application materials must be signed by the MDMF owner, including the application form and its accompanying registration materials and technical documents. For foreign-language documents, simplified Chinese translations must also be provided (Chinese translations can be signed by domestic agencies).
Further information
Read the original NMPA announcement on the implementation of the Medical Device Master Filing System in China.
Read the original CMDE announcement on clarifying the usage of MDMF.
It is our expertise to assist suppliers in protecting their production and raw material data, ensuring a secure and compliant entry into the Chinese medical device market. Contact Cisema to learn more about how we can support your MDMF application in China.
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