On 25 May 2026, Australian Therapeutic Goods Administration (TGA) announced an information session on Unique Device Identification (UDI) for clinical quality registries, highlighting upcoming regulatory requirements under Australia’s UDI framework for medical devices and in vitro diagnostic (IVD) devices. The session aims to support clinical quality registries and related stakeholders in understanding the role of UDI in strengthening device traceability and improving patient safety. The framework is intended to improve the speed and accuracy of identifying medical devices across healthcare settings, benefiting patients, healthcare professionals, hospitals and registries. The session will explain the UDI framework, implementation processes, and methods for accessing the AusUDID. It will also discuss how UDI information can be captured within clinical systems such as medical records, discharge summaries and registries, followed by a dedicated question-and-answer session for stakeholder.
Consult
