Medical Device Governance Program

The Clinical Excellence Commission is implementing the Therapeutic Goods Administration’s (TGA) Medical devices reforms by centralising mandatory reporting of adverse events associated with medical devices, embedding Unique Device Identification (UDI) standards for stronger tracking and traceability, and ensuring governance, safety and quality for personalised medical devices.

The TGA medical devices reforms aim to strengthen the regulation of medical devices in Australia, with a focus on improving patient safety and transparency. Key measures of the reforms including the introduction of UDI to enhance traceability, more rigorous pre-market assessments for high-risk devices, and stronger post-market surveillance, aim to detect and respond to safety issues swiftly. These reforms will also improve public access to information about medical devices and empower both clinicians and patients to make informed decisions about medical devices they use.