• 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
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • 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
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • NMPA Fast-Track Approvals: Applications and Approvals Passed

NMPA Fast-Track Approvals: Applications and Approvals Passed

Monday, 28 September 2020 / Published in Medical Device, News, NMPA Registration in China

NMPA Fast-Track Approvals: Applications and Approvals Passed

The NMPA (National Medical Products Administration) accepted 7 domestic and 1 overseas applications for fast-track approval and passed 2 other fast-track approvals for the following medical devices.

The “fast-track” for regulatory approval is a policy that was initiated in China from 2014. Whilst there have been no recent regulatory changes to the process, there has been an uptick in approvals as the system matures and more manufacturers seek to take advantage of the regulatory pathway.

AI software has been in the news frequently recently. Read our previous article about the developments for AI medical devices detecting diabetic retinopathy in conventional colour fundus photography.

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

Tagged under: AI medical devices, fast-track approval, innovative medical device, NMPA Green Channel

What you can read next

Various Cosmetic Regulatory Updates Supporting CSAR
Cosmetics enterprises quality and safety responsibilities
Cosmetics enterprises quality and safety responsibilities – Draft regulation issued
china compulsory certificate
Cisema Webinar: Certification in China – China Compulsory Certificate (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
    • Voluntary Product Certification
  • Publications
  • Seminars
  • Uncategorized
  • Webinars

Recent Posts

  • China cosmetics efficacy claims FAQ

    China cosmetics efficacy claims FAQ available to answer key questions

    China cosmetics efficacy claims FAQ is availabl...
  • China cosmetics GMP inspections

    China cosmetics GMP inspections points have been finalised

    China cosmetics GMP inspections points and judg...
  • China medical device quality safety responsibility

    China medical device quality and safety responsibility regulations come into force on March 1, 2023

    China medical device quality and safety respons...
  • China drug standards draft measures

    China drug standards draft measures have been published by the NMPA

    China drug standards draft measures have recent...
  • China special equipment safety supervision

    China special equipment safety supervision – draft provisions released

    China special equipment safety supervision regu...

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