• 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
  • 2019 Annual Report, Strengthening Scheme and Updates on Medical Device Mandatory Standards

2019 Annual Report, Strengthening Scheme and Updates on Medical Device Mandatory Standards

Friday, 21 August 2020 / Published in Medical Device, News

2019 Annual Report, Strengthening Scheme and Updates on Medical Device Mandatory Standards

On July 7, the NMPA (National Medical Products Administration) issued a notice addressing 6 action items to strengthen the mandatory standards for medical devices by:

  • Requiring all government units to acknowledge the standards’ legal status and significance
  • Enhancing the systematic procedure for standard updates
  • Enhancing the drafting and implementation procedures for standards
  • Training internal units to ensure the standards are successfully implemented and enforced
  • Streamlining the execution of technical review and evaluation procedures
  • Analyzing the effectiveness of standards to improve the quality

Mandatory standards in China are called GB standards (Guo Biao or national standards) and YY standards (industry standards). The notice explains the importance of the management and administration of mandatory standards, and expects more standards to be implemented in the near future.

On July 8, the NMPA issued a report covering the progress of China’s “five-year plan” and included a breakdown of the total existing and new standards for medical devices in 2019. According to the report, China has implemented a total of 1671 mandatory standards for medical devices, while 1451 of them are YY standards, 220 are GB standards.

Top 5 Product Scopes with the Most Standards

  • Medical electrical products and equipment: 339 standards (20.3%)
  • IVDs: 243 standards (14.5%)
  • Surgical implants: 209 standards (12.5%)
  • Dentistry products: 163 standards (9.8%)
  • Infusion products and equipment: 148 standards (9.8%)

By the end of 2019, 447 standards have been revised by the NMPA achieving 89% of the “five-year plan” target (500 standards). Currently, China is a member of the IMDRF (International Medical Device Regulation Forum), and contributed to transfrom 582 (90%) of the 670 ISO and IEC standards into Chinese standards. As a result, the China requirements are becoming clearer for overseas importing medical device product.

On June 30, the NMPA announced a list of new and amended YY standards:

  • 41 newly added YY standards
  • 2 amended YY standards (First Link and Second Link)

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

Tagged under: annual report, GB Standards, Guobiao, Mandatory Standards, YY standards

What you can read next

Extension of Cross-Border E-Commerce Policy
Changes of Health Food Functions Claims
China medical device adverse event monitoring
China Medical Device Adverse Event Monitoring Annual Report (2021)

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