• 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
  • About us
    • Company Profile
    • Partners
    • Testimonials
  • Locations
  • Events
    • Trade Fairs & Conferences
    • Seminars
    • Webinars
  • News & Knowledge
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • Pharmaceuticals & DMF
      • CCC
      • Pressure Vessels
    • Publications
    • Brochures & Whitepapers
    • Online Shop
    • FAQ – NMPA Registration – Medical Devices and IVDs
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • Draft Guideline Concerning OEM Quality Agreement for Medical Devices

Draft Guideline Concerning OEM Quality Agreement for Medical Devices

Monday, 20 December 2021 / Published in Medical Device, News, NMPA Registration in China

Draft Guideline Concerning OEM Quality Agreement for Medical Devices

On November 15, 2021, the NMPA (National Medical Products Administration) issued a draft guideline for writing OEM quality agreements in China. According to the draft guideline, registrants or filers shall sign this agreement with OEM manufacturers to specify the rights, obligations and responsibilities of both sides in the entire process of achieving product quality.

A complete medical device quality management system should be established by the OEM manufacturer, as well as meeting the requirements of the Good Manufacturing Practice for Medical Device.

Highlights

  • Contract production in the Guideline refers to the production activities carried out by entrusted manufacturer (hereinafter referred to as “entrusted Party”) when they are entrusted by medical device registration or filing units(hereinafter referred to as “entrusting Party”).
  • The guideline is not applicable to the following medical devices:
    • Implantable materials and artificial organs:
      1. Vascular stent and vascular stent system (except for peripheral vascular stent)
      2. Cardiac occluder, cardiac occluder system
      3. Artificial heart valve
      4. Plastic implant (agent)
    • Allogeneic medical devices
    • Some medical devices of animal origin:
      1. Repair materials for heart, nerve and dural
      2. Artificial skin
      3. Hemostatic and anti-adhesion materials used in human body
      4. Bone repair materials
      5. Other implantable medical devices directly created from animal tissues
    • Other medical devices:
      1. Pacemaker
      2. Implantable blood pump
      3. Implantable insulin pump.
  • The guidelines defines the basic elements of the quality agreement for OEM production.
  • The guideline provide the steps for protocol formulation and the principles and methods that should be considered in the protocol formulation.
  • A template of the quality agreement is provided in the appendix of the guideline.

On November 19, 2021, the NMPA (National Medical Products Administration) issued the draft catalogue of medical device products to be prohibited from OEM (Original Entrusted Manufacture) production in China. Read our separate blog post for more detailed information.

By Alice Liu and Jacky Li. If you would like support for drafting such agreements or for localization of your production in China, join our other customers and see what you’re missing out on by contacting us.

Tagged under: OEM production, Quality Agreement, Quality control

What you can read next

NMPA Implements the eCTD of Drug Application
Cosmetics Sample Test
China – Updates for voluntary product safety certification (instead CCC)

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
  • Publications
  • Seminars
  • Webinars

Recent Posts

  • China Webinar Cosmetics

    Webinar: China Cosmetics Ingredient Code Submission

    The webinar “China Cosmetics Ingredient C...
  • hainan communication sop

    Hainan Communication SOP for Medical Device Clinical RWD Applications (Trial)

    The Hainan Communication (SOP) Standard Operati...
  • china clinical application management

    China Clinical Application Management on Restrictive Medical Technologies – Catalogue and Specifications (2022 Edition)

    China clinical application management is an imp...
  • Cosmoprof worldwide bologna 2022

    Cosmoprof Worldwide Bologna 2022 – Meet with Cisema

    Cosmoprof Worldwide Bologna 2022 is the 53rd ed...
  • Measures for the supervision and administration of drug production

    Measures for the Supervision and Administration of Drug Production in China – A Recap

    Measures for the Supervision and Administration...

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
  • Events
  • News & Knowledge
  • Partners

Company

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

© 2021 Cisema. All rights reserved.

TOP
Cookies on Cisema
Learn more about Cisema's Privacy Policy.