In accordance with the NMPA (National Medical Products Administration) publication No. 66-2019, the UDI (Unique Identification System) will be mandatory for medical devices in China as of 01.10.2019.
There are currently the following two relevant guidelines:
• Rules for the Unique Identification System of Medical Devices
• YY / T 1630-2018 Fundamental Requirements for UDI
The UDI code application has to be submitted to ANCC (Article Numbering Center of China). Starting 01.10.2019, the registered UDI code has to be provided to the NMPA as part of initial registration, renewal or change applications. Prior to exporting to China, all newly registered products must be labeled with the UDI code.