NMPA released the list of manufacturers with master files submitted on August 8, 2022. 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 Document
- 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
- Zhejiang Xingyue Biotechnology: Silk Fibroin Master File
- Lincotai Bologna: Master Document for Medical Applications of Physical Vapor Deposition Titanium Niobium Nitride Coatings on Cobalt Chromium Molybdenum Substrates
- CStone: Pujihua® Clinical Research Materials Master File
- Qingdao Boyite Biomaterials: Medical Chitosan Raw Material Master File
- Jiangsu Jiangshan Juyuan Biotechnology: Recombinant Type III Humanized Collagen Raw Material Master File
- Cokes (Changzhou) Surface Treatment: Master Document of Surface Treatment Process for Medical Device Implants and Tools
On March 12, 2021, NMPA issued Notice regarding Medical Device Master Files Register. For more information on the notice please click HERE
Medical device master file in China is a technical document that owner of the file submits to NMPA Center of Medical Device Evaluation (CMDE) to authorize the applicant to use in the medical device registration but does not directly disclose the content to the applicant. The purpose of the medical device master file is to protect the technical secrets of the documents’ owner and to avoid the repeated submission of the same technical documents by different parties.
Legal representative will 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