• 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
  • UDI Requirements for the First Batch of Medical Devices

UDI Requirements for the First Batch of Medical Devices

Friday, 15 November 2019 / Published in Medical Device, News

UDI Requirements for the First Batch of Medical Devices

Following the announcement of the implementation of the UDI for Medical Devices, China NMPA held an informational workshop seminar and outlined the requirements for the first batch of products requiring UDI.


Unique Identification Code Requirements

  • The UDI code must be labelled for products manufactured on or from 1 October 2020 onwards
  • The date of manufacture must be included in the UDI code
  • Different UDI codes can be assigned according to the different packaging specifications, but must be clearly readable and identifiable by the personnel, otherwise, it must suffice to be entered manually
  • Code agencies without a legal entity in China cannot provide services to maintain the UDI database. At present, only the two following code agencies can meet the requirements according to the Chinese regulations:
    • GS1 (for GS1 codes)
    • ZIIOT (for MA codes)

*Or request the issuing agency to establish a legal entity in China to provide services according to UDI requirements


Unique Identification Registration System – Submission Requirements

From 1 October 2020 onwards, the registered applicant/registrant must submit the product identification (DI) in the registration management system for:

  • First registration
  • Renewal registration
  • Product Change Application


Unique Identification Database – Submission Requirements

For the medical devices produced before 1 October 2020, the enterprises/registrant shall:

  1. Register in the UDI database system
  2. Enter the product information:
    • Upload the product identification (DI)
    • Related data of the minimum sales unit and higher level packaging to the medical device only according to the relevant standards or specifications

*The Identification database (currently under construction) will commence by December 2019
*Specific requirements for NMPA legal agents and distributors are to follow


Summary

UDI application

If you already use UDIs issued by GS1 or ZIIOT, they are acknowledged in China.

Otherwise:

  • Apply for a UDI at GS1 or ZIIOT in your home country
  • Or entrust your NMPA Legal Agent to apply for a UDI at GS1 or ZIIOT in China


UDI filing

Register & upload the UDI code to the NMPA UDI database


UDI implementation: October 1st, 2020

  • When applying for new registration, renewal or product change, submit approved UDI code
  • Products with production date later than 01.10.2020 must be labelled with UDI code

 

Click here to view the first batch of medical devices requiring UDI.

For further information on the above topics, please contact us.

What you can read next

Filing of Imported Non-Special Use Cosmetics with Beijing MPA
2 Health Food Products Draft Regulations Issued for Public Consultation
Updates on the Clinical Trial Exemption List for Medical Devices and IVDs

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