TGA overhauls medical device reporting rules

The Therapeutic Goods Administration (TGA) is introducing mandatory reporting measures for medical device-related adverse events across all Australian hospitals.

From 21 March 2026, public, private, and day hospitals will be required to report injuries or suspected injuries linked to medical devices directly to the TGA. This shift, backed by the Office of Impact Analysis within the Department of the Prime Minister and Cabinet, is designed to strengthen national oversight and accelerate responses to emerging safety signals.

The reform is a response to identified gaps in device safety reporting, notably highlighted during the 2017-2018 Senate Inquiry into transvaginal mesh implants. The inquiry exposed systemic failures in information sharing between clinicians, hospitals, and regulators that delayed the TGA’s ability to intervene more quickly.

Currently, only medical device manufacturers and sponsors are obligated to report adverse events. Voluntary reporting by hospitals has been inconsistent, with recent stakeholder consultations revealing key barriers including lack of awareness, time constraints, complexity in identifying medical device related adverse events, and inconsistent systems and processes across facilities. Many long-term device failures also surface well after implantation, often in unrelated healthcare settings, further complicating reporting.

Professor Anthony Lawler, Head of the TGA, stated “We welcome the additional data that hospitals will now provide under this new measure. This enhanced reporting will play a critical role in helping the TGA to identify potential safety concerns earlier. By identifying these signals sooner, we can act quickly and appropriately to protect the health and safety of all Australians.”

The new obligations will be rolled out in stages, beginning with high-risk medical devices, including Class III devices, active implantable medical devices (AIMDs), and Class 4 in vitro diagnostics (IVDs). Broader reporting requirements for medium-risk devices will follow once systems are in place.

The rationale is clear: Class III devices represent 10% of entries on the Australian Register of Therapeutic Goods (ARTG) but account for nearly half (49.5%) of all reported adverse events between Q1 2019 and Q4 2023. In contrast, Class I devices, comprising over half of all registered devices, were linked to just 4.4% of reports.

Further strengthening the TGA’s oversight, manufacturers will be required to implement barcodes on all packaging and labelling and submit the data to support the rollout of the Unique Device Identification (UDI) system. Mandatory UDI compliance for implanted devices will commence in July 2026.

UDI data will integrate into hospital systems and patient records, including My Health Record, enabling device identification and longitudinal tracking. A public UDI database will also be maintained to improve transparency and empower patients with direct access to their device information.

Professor Robyn Langham, Chief Medical Advisor at the TGA, said “I encourage all healthcare facilities, surgeons and GPs to explore the powerful capabilities of UDI and the valuable opportunities it presents for enhancing patient care and clinical data systems.

“UDI is set to play a vital role in empowering patients with full transparency regarding their medical devices, ultimately supporting safer and more informed healthcare decisions.”

To cement these changes, the Australian Commission on Safety and Quality in Health Care will incorporate the new reporting standards into hospital accreditation requirements from 2030.

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.