China UDI Submission Taking Effect Jan 1, 2021

2021-01-19

China UDI system for the first group of devices will take effect on January 1, 2021. For the medical devices listed in the “First Group of Unique Device Identification Devices”, when applying for the initial registration, registration renewal or the change of registration, the applicant or registrant shall submit the unique identifier of unique device identification (hereinafter referred to as UDI-DI) in the registration management system.

NMPA released a notice about UDI-DI on December 29, 2020.

For the medical devices listed in the “First Group of Unique Device Identification Devices”, when submitting the application forms for initial registration, registration renewal or the change of registration in eRPS, the UDI-DI information should be filled in and uploaded according to the template provided on the website.
Otherwise, the application form cannot be submitted, and the registration dossiers will not be accepted.
UDI-DIshould be created by the applicant or registrant in accordance with the Rules for Unique Device Identification System

For the official updated list of First Group of Unique Device Identification Devices, please email info@inspirativemed.com.

Services We Offer

As an NMPA certified legal representative, we help you complete UDI China implementation process from defining UDI form to uploading DI (device identifier) to database:

Define UDI form

figure out the differences of classification code between old and new Medical Device Classification Catalogs

Identify issuing agency

choose from GS1 China, Zhongguancun Industry & Information Research Institute of Two-Dimensional Code Technology, Ali Health, Mashangfangxin Platform, etc.
The unique identification report for the previous year shall be submitted by code issuing agencies to the NMPA before January 31 of each year.

Report DI data

during registration/filing/change and before the product is put on the market for sale
choose one way of reporting: interface exchange, online reporting, or data template exchange

Upload DI to database

total 50 data attributes (25 mandatory, 10 conditional mandatory and 15 optional)
for devices produced since January 1, 2021, before the commercialization of the products, their identifiers shall be submitted

Communication

advocate with NMPA during the pilot and regulation/standards development.

Link: https://www.cmde.org.cn/CL0004/22220.html