From October 1, 2020 onwards, the registered applicant/registrant of medical devices listed in the first batch must submit the product identification (DI) in the registration management system for:
- First registrations
- Renewal registrations
- Product change applications
The UDI requirements for the first batch of medical devices were announced by the NMPA (National Medical Products Administration) on October 15, 2019. Click here to view the first batch of medical devices requiring UDI.
In addition, the UDI code must be labelled for products manufactured on or from October 1, 2020 onwards.
More information about the UDI requirements for medical devices in China can be found here.
Read our article about the NMPA UDI database officially opening to the public in March 2020.
By Jacky Li. Contact Cisema if you would like to learn more.