China NMPA published a notice "Further Clarify the Registration and Use of Medical Device Master Files" on January 18, 2023. To protect medical device raw materials' intellectual property rights, manufacturers can utilize the master file system. In addition to protect the IP, the raw material suppliers can benefit from the efficiency of registration approval process when they supplier to multiple finished goods manufacturers in China. They can direct their finished goods clients to reference the master files with NMPA.
The notice states:
- Master files are submitted directly by its owner to the medical device regulatory agency. It is to authorize the medical device applicant to use for registration. The submission of the master file is voluntary.
- The master file registration mainly involves medical device raw materials. It applies for the registration, modification, clinical trial approval, etc. of imported Class II, Class III, and China Class III medical devices (IVDs included).
- The master file system protects the intellectual property rights of its owner (raw materials' manufacturers), facilitates the medical device applicants' selection of raw materials and key components, and simplifies registration.
- The medical device applicant shall assist the owner to establish the master file. Device applicant takes full responsibility for the safety and efficacy of the medical device. The master file will be granted a filing code after submission. The CMDE will review the master file data once the device application is submitted.
According to the CMDE website, as of January 18, 2023, over 120 owners have filed the master files, some of which have multiple raw materials or components submitted. Many overseas companies are on the list. It includes but not limited to the following:
- Siemens (Shenzhen) Magnetic Resonance: Soul-Man System Supplementary Material Master File
- Takeda: Mobocertinib Capsule Drug Clinical Trial Master File
- Integra Life Technologies: Absorbable Collagen Sponge
- Danko Metal Finish: Titanium and Titanium Alloy Surgical Implantable Anodized Film Master File
- Covestro: MAKROLON- Polycarbonate Resin Raw Material Master File
- Lincotai Bologna: Master File for Medical Applications of Physical Vapor Deposition Titanium Niobium Nitride Coatings on Cobalt Chromium Molybdenum Substrates
- CStone: Pujihua® Clinical Research Materials Master File
- Cokes (Changzhou) Surface Treatment: Master File of Surface Treatment Process for Medical Device Implants and Tools
NMPA encourages overseas manufacturers of medical devices to create master files in accordance with the relevant requirements in NMPA announcements released on March 12, 2021. The establishment of master files helps simplify the medical device registration processes and maintain confidentiality.
Love to hear any challenges during your Master File submission to NMPA. Please feel free to email me if you have questions.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------