Eight manufacturers became master file owners for their raw materials or key components so far in 2023, including two foreign producers: Covidien and Invibio.
Full List of 8 Manufacturers in 2023
- Covidien: Tracheostomy cannula
- Invibio: Polyetheretherketone
- Zhejiang Xingyue: Silk mesh
- Huaxi Bio: Sodium hyaluronate for injection filling
- Huaxi Bio: Sodium hyaluronate for cosmetic injection
- Shandong Weigao: Prefilled syringe assembly (without needle)
- Guangzhou Taiyuan: Recombinant type III humanized collagen
- Beijing Ierkang: Bovine type I collagen
- Suzhou Dingan: Hydroxyapatite powder for plasma spraying
- Other Imported Raw Materials
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 Raw Material 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 master document system protects the intellectual property rights of the master file owner (raw materials’ manufacturers) and facilitates the medical device applicants’ selection of raw materials and key components, simplifying 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 reviews the master file data when the device application begins.
On March 12, 2021, 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 NMPA certified 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