• EnglishEnglish
    • Deutsch Deutsch
    • Italiano Italiano
    • Français Français
    • 日本語 日本語
    • 한국어 한국어

CISEMA - China Zertifizierung, Einkauf und Qualitätssicherung

  • Services
    • NMPA Registration – Medical Devices and IVDs
    • NMPA Registration & DMF – Pharmaceuticals
    • NMPA Registration – Cosmetics
    • NMPA Registration – Health Food
    • CML (China Manufacture Licence) – Pressure vessels
    • CCC (China Compulsory Certification) – Industrial and consumer goods
    • Others
      • Sourcing and Quality Control
      • Logistics and Customs Support
      • Sales Support
  • Events
    • Trade Fairs & Conferences
    • Seminars
    • Webinars
  • News & Knowledge
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • Pharmaceuticals & DMF
      • CCC
      • Pressure Vessels
    • Whitepapers
    • FAQ – NMPA Registration – Medical Devices and IVDs
    • Newsletter Sign Up
    • Others
      • Publications
      • Online Shop
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • Newsletter Sign Up
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • NMPA Introduces the Medical Device Master Filing System

NMPA Introduces the Medical Device Master Filing System

Wednesday, 24 March 2021 / Published in Medical Device, News, NMPA Registration in China

NMPA Introduces the Medical Device Master Filing System

On March 12, 2021, the NMPA (National Medical Products Administration) announced (No.36-2021) the implementation of a medical device master filing system in China with immediate effect. This means that materials and component suppliers won’t need to provide confidential information to the manufacturer and instead can provide their master file code.

Purpose

The medical device master file (MDMF) contains technical data information (e.g., raw materials, ingredients, subassemblies, or accessories) of the medical device, and can only be authorized by the respective MDMF owner (e.g., raw material supplier) to support the device’s NMPA registration. The purpose of the MDMF is to protect the intellectual property of all parties involved. For instance, the raw material supplier can avoid sharing any confidential information to the NMPA registration applicant.

Scope

The MDMF can support the applications of Class II and Class III importing medical devices, as well as Class III domestic medical devices for NMPA registrations, registration renewals, changes in licensing items, and clinical trials.

Basic Principles

  • The registration of the MDMF is voluntary.
  • Overseas MDMF holders must authorize a local agent / representative in China to handle urgent matters (e.g., responding to regulatory authorities, keeping the MDMF details up-to-date).
  • The contact details of the local agent / representative should be registered in the MDMF and updated for any changes.

MDMF Format

As the MDMF covers the technical data information required in the NMPA registration dossier, however, the MDMF format may not be suitable for some specific information (e.g. IVD raw materials) in the dossier submission. Feel free to consult our Cisema specialists to check if your product complies with the MDMF format requirements.

Digital Certificate for the MDMF Registration

From March 15, 2021 onwards, local MDMF holders or local representatives (for overseas MDMF holders) can apply for a digital certificate of MDMF Registration via the CMDE’s (Center for Medical Device Evaluation) eRPS system. This digital certificate is known as a “CA Certificate”. However, it won’t be necessary for those who are already certificate holders.

After applying for the CA certificate, the applicants can refer to the requirements listed on the eRPS system to prepare and submit the dossier for the MDMF registration.

Applicants applying for the medical device registration in China are responsible for the dossier submitted by the MDMF holders, and shall ensure that all requirements are met.

By Jacky Li. Contact Cisema if you would like to learn more.

Tagged under: Master File, MDMF, medical device raw materials

What you can read next

1,002 Institutions in China Qualified for Clinical Trials
NMPA – New Application Deadlines for Cosmetics
Fast-Track Approval Updates in October & November 2020

Search

Categories

  • Fairs & Events
  • News
    • CCC
    • CEL
    • CML, SELO
    • Medical Devices Listing in Hong Kong
    • NMPA Registration in China
      • Cosmetics
      • Health Food
      • Medical Device
      • Pharmaceuticals & DMF
    • RoHS
    • Voluntary Product Certification
  • Publications
  • Seminars
  • Uncategorized
  • Webinars

Recent Posts

  • Submission of safety information for cosmetics ingredients

    Submission of safety information for cosmetics raw materials – Draft guidelines issued

    Submission of safety information for cosmetics ...
  • avoid animal testing in Chinaweb-2023

    How to avoid animal testing in China for cosmetics | Cisema Webinar

    China’s beauty and cosmetic market has be...
  • guidelines for medical devices registration

    Guidelines for medical devices registration in China – New development plans in 2023

    Guidelines for medical devices registration in ...
  • China DMF of API

    China DMF of API, Excipient & Packaging Materials: Market & Regulatory | Cisema Webinar

    “China DMF of API, Excipient & Packag...
  • pre-phase III drug clinical trial meeting guidelines

    Pre-phase III drug clinical trial meeting guidelines released

    Pre-phase III drug clinical trial meeting guide...

Archive

Cisema

With twelve locations and over ninety highly qualified employees, Cisema can offer you optimal support in China.

Services

  • Certification
  • Sourcing and Quality Control
  • Logistics and Customs Support
  • Sales Support

Dialogue

  • Contact us
  • Newsletter Signup
  • Events
  • News & Knowledge
  • Partners

Company

  • GTC
  • Privacy Statement
  • Legal Notice
  • About us
  • Locations
  • GET SOCIAL

© 2021 Cisema. All rights reserved.

TOP