UDI system responsibilities

The Unique Device Identification (UDI) system relies on manufacturers, sponsors, healthcare providers and the Therapeutic Goods Administration (TGA). Each stakeholder has a role in supporting the UDI system.

At a high level:

• Manufacturers assign Unique Device Identifiers (UDIs), apply UDI labels and maintain device information.
• Sponsors submit and maintain UDI records in the Australian UDI Database (AusUDID) and ensure devices meet Australian UDI requirements.
• The TGA administers the AusUDID, monitors compliance and uses UDI information to support regulatory activities, including post-market surveillance and recalls.
• Healthcare providers can incorporate UDI into clinical, supply chain and patient safety processes to support traceability, recalls, adverse event reporting and inventory management.

The UDI system delivers the greatest value when these stakeholders work together to support consistent device identification from manufacture through to patient care and post-market activities.