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2023 China NMPA Bluebook is here:

Intellectual Property: Submit Master Files to Protect Your Raw Materials


nmpa guidelines for nanomaterials

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

According to the CMDE website, as of January 18, 2023, over 120 owners have obtained 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 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. 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.

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