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.