With an estimated medical device market size of over 50 billion USD and growth rate of 10% per year, China has become an attractive market, full of opportunities, for foreign medical device companies. Foreign manufacturers of medical device components and raw materials can benefit from these opportunities by doing a Master File (MF) in China.
In March 2021, the NMPA issued Announcement No.36 regarding Medical Device Master File Registration, which became effective immediately. The scope of this announcement applies to imported Class II and Class III medical device components and raw materials. If medical device component and raw material suppliers file a MF to the NMPA’s Center of Medical Device Evaluation (CMDE), they will be able to provide technical data to the CMDE without having to share this information with the final medical device applicant during the registration process.
Even though the MF is a voluntary system, doing a MF in China can bring major benefits to raw material and component suppliers. Instead of sharing technical data with the final medical device manufacturer, component and raw material suppliers only need to provide the master file number to support the final medical device’s NMPA registration effort, thus protecting their intellectual property and “know-how”. Since one MF can be used for the registration of different medical device products, filing a MF also helps save time and effort by avoiding repeated submissions for multiple device products.
Companies can submit master file documents, which must be translated into Chinese, directly to the CMDE via the master file document registration platform. The submission documents mainly focus on the manufacturing process, chemical composition, mechanical and chemical performance, biocompatibility test, etc. After the CMDE reviews the submission for its completeness, a MF number will be issued, which can later be used for multiple medical device product registrations. The CMDE will only review the master file documents in detail when a medical device application that references the MF number is submitted. However, before this number can be used in a medical device registration application, the MF owner must issue a Letter of Authorization to the medical device applicant.
The MF must be submitted by a local representative in China, who has access to the electronic medical device registration management system (the eRPS system). Therefore, foreign manufacturers must appoint a local Chinese representative who will be responsible for filing the MF and communicating with the local authority. The Chinese local agent can also hold your registration and make amendments as needed.
With an experienced team of on-the-ground Chinese regulatory experts, PBM can be your local representative to submit your MF. Contact us if you want to learn more about doing a MF in China.