On March 12, 2021, the NMPA (National Medical Products Administration) announced (No.36-2021) the implementation of a medical device master filing system in China with immediate effect. This means that materials and component suppliers won’t need to provide confidential information to the manufacturer and instead can provide their master file code.
Purpose
The medical device master file (MDMF) contains technical data information (e.g., raw materials, ingredients, subassemblies, or accessories) of the medical device, and can only be authorized by the respective MDMF owner (e.g., raw material supplier) to support the device’s NMPA registration. The purpose of the MDMF is to protect the intellectual property of all parties involved. For instance, the raw material supplier can avoid sharing any confidential information to the NMPA registration applicant.
Scope
The MDMF can support the applications of Class II and Class III importing medical devices, as well as Class III domestic medical devices for NMPA registrations, registration renewals, changes in licensing items, and clinical trials.
Basic Principles
- The registration of the MDMF is voluntary.
- Overseas MDMF holders must authorize a local agent / representative in China to handle urgent matters (e.g., responding to regulatory authorities, keeping the MDMF details up-to-date).
- The contact details of the local agent / representative should be registered in the MDMF and updated for any changes.
MDMF Format
As the MDMF covers the technical data information required in the NMPA registration dossier, however, the MDMF format may not be suitable for some specific information (e.g. IVD raw materials) in the dossier submission. Feel free to consult our Cisema specialists to check if your product complies with the MDMF format requirements.
Digital Certificate for the MDMF Registration
From March 15, 2021 onwards, local MDMF holders or local representatives (for overseas MDMF holders) can apply for a digital certificate of MDMF Registration via the CMDE’s (Center for Medical Device Evaluation) eRPS system. This digital certificate is known as a “CA Certificate”. However, it won’t 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 MDMF registration.
Applicants applying for the medical device registration in China are responsible for the dossier submitted by the MDMF holders, and shall ensure that all requirements are met.
By Jacky Li. Contact Cisema if you would like to learn more.
