Fourteen Medical Devices Go into Hainan Real-World Data PathwayJanuary 15, 2021
Feedbacks Needed for DR and Ultrasonic Diagnostic SoftwareJanuary 18, 2021
China’s UDI system for the submission of 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” list, 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.
The 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-DI should 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@ChinaMedDevice.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
- A total of 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
- Advocate with the NMPA during the pilot and regulation/standards development.