The NMPA renewed the list of raw material master files on August 14, 2023. Four foreign manufacturers became master file owners for their raw materials or key components in August: Smith Nephew, Covidien, Merck, Nitta Gelatin.
The master file system is created to protect the intellectual property rights of the master file owner (raw materials’ manufacturers) and facilitate the medical device applicants’ selection of raw materials and key components, simplifying registration.
Full List of Raw Material Master Files
- Smith Nephew: Superabsorbent layer
- Smith Nephew: 7.5 Mard highly crosslinked ultra-high molecular weight polyethylene
- Smith Nephew: 10 Mard highly crosslinked ultra-high molecular weight polyethylene
- Covidien: Polycarbonate resin – MAKROLON 2458 010110
- Covidien: Polycarbonate resin – MAKROLON 2858 010110
- Merck: Clinical research report of PD-L1 antibody reagent (immunohistochemical method) to increase the clinical indications
- Nitta Gelatin: beMatrix collagen
Other Imported Raw Materials
Many overseas companies have become master file owners. It includes but not limited to the following:
- Siemens (Shenzhen) Magnetic Resonance: Soul-Man System
- 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
Master File System
The 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 rights, it asks manufacturers to pay attention to the master file system.
The notice says that:
- The master document is submitted directly by its owner to the medical device regulatory agency. It is to authorize the medical device applicant to use in the registration. The submission of the master file is voluntary.
- The main 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 domestic Class III medical devices.
- 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 reviews the master file data when the device application begins.
On March 12, 2021, the NMPA issued Notice regarding Medical Device Master Files Register. Read more information on the notice.
Legal representatives play a big role in the master files for overseas device applicants and owners. Authorizing a legal agent is a must for foreign manufacturers to communicate filling process and renew master files in time. The owners of master file shall specify the name, address, contact and authorized authority for the legal representative.
China Med Device, LLC is qualified NMPA legal representative. We can help you fulfill the pre and post market legal agent requirements without your need to setup office in China. Translation service is provided. info@ChinaMedDevice.com