• 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
  • China Medical Device Standards and Technical Review Guidelines Issued in 2021 – Overview

China Medical Device Standards and Technical Review Guidelines Issued in 2021 – Overview

China Medical Device Standards
Saturday, 26 February 2022 / Published in Medical Device, News, NMPA Registration in China

China Medical Device Standards and Technical Review Guidelines Issued in 2021 – Overview

China medical device standards have 35 new national standards and 146 new industrial standards with a total increase of 21% as compared to 2020. On January 19, 2022, the NIFDC (National Institutes for Food and Drug Control) announced a list of 181 new medical device standards issued in 2021.

As of December 2021, 1,849 medical device standards have been recorded:

Highlights – China medical device standards

  • 235 National standards
    • 91 GB Standards
    • 144 GB/T Standards
  • 1,614 Industry standards
    • 298 YY Standards
    • 1,316 YY/T Standards

The code name of the mandatory national standard is “GB”, and the recommended national standard is “GB/T”. The code name of the mandatory industry standard is “YY”, and the code name of the recommended industry standard is “YY/T”.

On January 25, 2022, the CMDE (Center for Medical Device Evaluation) under the NMPA (National Medical Products Administration) announced a list of 64 technical review guidelines issued and implemented in 2021.

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

Tagged under: GB Standards, Industry Standards, Mandatory Standards, National Standards, YY standards

What you can read next

Publication of further definitions of CCC for EX products (explosion protection)
Marketing Authorization Holder (MAH)
China cosmetics filing FAQs
China cosmetics filing FAQs – November and December 2022

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

  • laser therapy devices

    Clinical evaluation of laser therapy devices – New guidelines issued

    Clinical evaluation of laser therapy devices ha...
  • dental implant system

    Clinical evaluation of dental implant systems in China – New guidelines issued

    Clinical evaluation of dental implant system ha...
  • China Medical Device Webinar

    China Medical Device Webinar with AdvaMed Accel for U.S. exporters

    The China Medical Device Webinar will be featur...
  • webinar_medical-device-market-authorisation

    Cisema presenting at FORUM Institut: Medical device marketing authorisation for advanced – Masterclass China

    Cisema is delighted to hold a Masterclass with ...
  • generative AI services

    China’s generative AI interim measures now in effect

    China’s generative AI interim measures fo...

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