Eighteen months after launching a pilot system to improve the tracking of medical devices, Chinese regulators are starting to build the system out, announcing the first group of products that will be required to employ the Unique Medical Device Identification (UDI) system.
Among the devices affected by the Dec. 29 notice from the National Medical Products Administration (NMPA) are high-risk Class 3 implantable medical devices. These include intravascular and non-vascular interventional devices, orthopedic and neurosurgical implants, pacemakers, and high-value medical consumables. The devices will be required to be labeled via a set of alphanumeric and linear bar codes to identify and monitor each element of a medical device from the moment it is produced and enters the supply chain through its lifetime.
When fully implemented nationally, the UDI system will be required on most medical devices sold in China. 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.