China NMPA previously 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 supply to multiple finished goods manufacturers in China. They can direct their finished goods clients to reference the master files with NMPA.
According to NMPA website, over 120 owners have filed the master files, some of which have multiple raw materials or components submitted. Eight manufacturers became master file owners for their raw materials or key components so far in 2023, including two imported manufacturers: Covidien and Invibio.
Full List in 2023
1. Covidien: Tracheostomy cannula
2. Invibio: Polyetheretherketone
3. Zhejiang Xingyue: Silk mesh
4. Huaxi Bio: Sodium hyaluronate for injection filling
5. Huaxi Bio: Sodium hyaluronate for cosmetic injection
6. Shandong Weigao: Prefilled syringe assembly (without needle)
7. Guangzhou Taiyuan: Recombinant type III humanized collagen
8. Beijing Ierkang: Bovine type I collagen
9. Suzhou Dingan: Hydroxyapatite powder for plasma spraying
Many overseas companies are already on the list. It includes but not limited to the following:
1. Siemens (Shenzhen) Magnetic Resonance: Soul-Man System Supplementary Material Master File
2. Takeda: Mobocertinib Capsule Drug Clinical Trial Master File
3. Integra Life Technologies: Absorbable Collagen Sponge
4. Danko Metal Finish: Titanium and Titanium Alloy Surgical Implantable Anodized Film Master File
5. Covestro: MAKROLON- Polycarbonate Resin Raw Material Master File
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------------------------------