• 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 – Cosmetics
    • NMPA Registration – Health Food
    • DMF (Drug Master Filing) – Pharmaceutical Products
    • CCC (China Compulsory Certification) – Industrial and consumer goods
    • CML (China Manufacture Licence) – Pressure vessels
    • 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 & Information
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • DMF
      • CCC
      • Pressure Vessels
    • Publications
    • Brochure
    • Online Shop
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • Unique Identification System (UDI) of Medical Devices

Unique Identification System (UDI) of Medical Devices

Tuesday, 03 September 2019 / Published in Medical Device, News

Unique Identification System (UDI) of Medical Devices

In accordance with the NMPA (National Medical Products Administration) publication No. 66-2019, the UDI (Unique Identification System) will be mandatory for medical devices in China as of 01.10.2019.

There are currently the following two relevant guidelines:
• Rules for the Unique Identification System of Medical Devices
• YY / T 1630-2018 Fundamental Requirements for UDI

The UDI code application has to be submitted to ANCC (Article Numbering Center of China). Starting 01.10.2019, the registered UDI code has to be provided to the NMPA as part of initial registration, renewal or change applications. Prior to exporting to China, all newly registered products must be labeled with the UDI code.

Tagged under: Medical Devices, UDI, Unique Identification System

What you can read next

Quality Control on Coronary Stents Increased Following China’s Recent Centralized Procurement Program
Certified Expert
New Integrated Custom-Inspection Declaration System

Search

Categories

  • Fairs & Events
  • News
    • CCC
    • CEL
    • CML, SELO
    • Medical Devices Listing in Hong Kong
    • NMPA Registration in China
      • Cosmetics
      • Drug Master Filing
      • Health Food
      • Medical Device
    • RoHS
  • Publications
  • Seminars
  • Webinars

Recent Posts

  • Updates on the Medical Device Classification Catalogue in China

    On December 31, 2020, the NMPA announced (No.14...
  • Cisema Partners with Advamed

    Cisema is delighted to announce it is now an as...
  • Guidelines for Sampling Testing on Organic Foods

    On December 4, 2020, the CNCA (Certification an...
  • Draft of Prohibited List and Existing List of Cosmetic Ingredients Announced

    On January 22, 2021, the NIFDC (China National ...
  • Guideline and Standard Update for Medical Devices & IVDs in January and February 2021

    China Regulatory Guidelines Issued / Updated Th...

Archive

Cisema

With nine 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 & Information
  • Partners

Company

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

© 2019 Cisema. All rights reserved.

TOP