• 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’s New Standard for Medical Electrical Equipment

China’s New Standard for Medical Electrical Equipment

China’s New Standard for Medical Electrical Equipment
Wednesday, 03 June 2020 / Published in Medical Device

China’s New Standard for Medical Electrical Equipment

On 09.04.2020, the Standardization Administration of China newly released GB 9706.1-2020 to replace GB 9706.1-2007 and GB 9706.15-2008 addressing the general requirements for the basic safety and essential performance of the medical electrical equipment. The replacement will take effect in 2023.

The new standard GB 9706.1-2020, equivalent to IEC 60601-1:2012, was announced to be officially implemented on May 1, 2023. The following table shows the transformation from GB 9706.1-1988 to GB 9706.1-2020 and indicates the corresponding IEC standards:

Chinas-New-Standard-for-Medical-Electrical-Equipment

Since 01.07.2008, the GB 9706.1-2007 had been officially implemented as the mandatory standard to ensure the safety of medical electrical equipment available in the China market. In 2014, there was a revision project approved, however, due to the modification of its corresponding standard IEC 60601-1:2005, the new version was never officially published.

IEC 60601-1:2012 had been adopted by overseas manufacturers since 2012, whilst China continued to comply with GB 9706.1-2007. The China GB national standard will be replaced by GB 9706.1-2020 in 2023.

By Jacky Li. Contact Cisema to learn more.

Tagged under: GB, Guobiao, IEC, Medical Electrical Equipment

What you can read next

NMPA report on the registration of medical devices in 2013, 2014, 2015
medical device qms audit
Medical device QMS audit guidelines for product registration are open for comment
Webinar in cooperation with WVIB in Freiburg/Germany

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