China Expands Use of Unique Device Identification System for Medical Devices

Moving to rapidly put in place its new Unique Medical Device Identification (UDI) system to track medical devices, Chinese regulators have announced the second group of devices that will be required to employ the system.

All Class 3 medical devices will be affected by the May announcement by the National Medical Products Administration (NMPA). The new requirements are to go into effect on January 1, 2022. Since January of this year, 69 high-risk implantable medical devices have already been required to use the UDI tracking system.

When fully implemented nationally, the UDI system will be mandated for most medical devices sold in China. The devices will be required to be labeled via a set of alphanumeric and linear barcodes to identify and monitor each element of a medical device from the moment it is produced and enters the supply chain through its lifetime. Manufacturers will be responsible for adhering to government guidelines when implementing the system on their products. Ultimately the system will include a database accessible to researchers and the public.