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Australia: New Australian Measures to Improve Medical Device Oversight

Australians who depend on medical devices will soon benefit from significant enhancements in the way device-related safety issues are identified, reported, and managed. For the millions of Australians who rely on pacemakers, joint implants, insulin pumps, and other critical medical devices, these changes are more than policy but peace of mind.


Led by the Therapeutic Goods Administration (TGA), these new measures aim to catch problems earlier, respond faster, and give both patients and healthcare providers the information they need to make safe and informed decisions.


Mandatory Hospital Reporting of Device-Related Adverse Events

Starting 21 March 2026, every hospital in Australia, including public, private, and day hospitals, will be required to report medical device-related injuries or suspected injuries to the TGA.


This change will enable the TGA to detect safety concerns much earlier. According to the TGA, this additional hospital data will be essential for identifying potential risks sooner and allowing timely action to protect public health.


To support ongoing improvements, the Australian Commission on Safety and Quality in Health Care will incorporate these reporting obligations into hospital accreditation standards starting in 2030.


Introduction of the Unique Device Identification (UDI) System

Imagine being able to scan a medical device’s barcode and instantly access its entire history. That’s the promise of Australia’s new UDI system. From July 2026, all implanted medical devices must have a unique barcode on their packaging, and manufacturers will need to submit this data to the TGA.

This information can be integrated into the hospital system and go far beyond logistics:

  • Hospitals can link devices directly to patient records and digital systems like My Health Record

  • Patients will be able to look up details of their devices in a public database

  • Doctors and surgeons can make better-informed decisions with clear, traceable data


TGA encouraged healthcare facilities and practitioners to explore UDI as a way to improve patient care, data accuracy, and clinical decision-making. The system is expected to offer greater transparency, empowering patients to be more informed about the devices used in their treatment.


Improved National Recall Processes

Another key improvement is the rollout of a stronger and more transparent national recall system for therapeutic goods. These changes aim to make it easier for manufacturers and users to initiate and report product recalls and to help the TGA respond more effectively.


Key features of the new recall process include:

  • Clearer and more simplified recall terminology

  • Streamlined procedures for all parties involved

  • Enhanced recall powers granted to the TGA

  • Improved communication with patients, healthcare professionals, and users


These improvements are expected to ensure patients and providers aren’t left in the dark during critical moments.



These reforms signal a robust commitment by the Australian Government to prioritize patient safety in the medical device landscape. With improved data, greater transparency, and streamlined regulatory processes, Australia is taking critical steps to ensure that healthcare remains both safe and responsive to emerging risks.


As these initiatives roll out over the coming years, healthcare providers, manufacturers, and patients alike will be empowered with better tools, clearer information, and enhanced safeguards to support informed decisions and high-quality care.


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