On 30 June 2025, Australia’s healthcare products regulator, the Therapeutic Goods Administration (TGA), announced regulatory reforms aimed at enhancing the safety of medical devices in Australia through mandatory reporting, including reporting of adverse events by hospitals. We look at the proposed changes and implications for stakeholders.
Mandatory reporting of adverse events
From 21 March 2026, all public, private and day hospitals in Australia will be required to report medical device-related injuries or suspected injuries to the TGA. This mandatory reporting is designed to help the TGA identify safety issues more promptly, enabling a quicker response from authorities when needed to enhance patient safety. To support this initiative, the Australian Commission on Safety and Quality in Health Care will incorporate these reporting requirements into hospital accreditation standards from 2030.
Implementation of the Unique Device Identification (UDI) system
Manufacturers supplying medical devices in Australia must use barcodes to identify their products on all packaging and labelling, and submit this data to the TGA. Mandatory compliance with the UDI system for implanted devices will commence from July 2026. The UDI information can be integrated into hospital systems and patient records, including MyHealth Records, to accurately identify the specific medical device used. The information will also be available on a public database, where patients can access details about their medical device.
Enhanced national recall procedures
The TGA has introduced what it is calling a 'stronger and more transparent process' for recalling therapeutic goods in Australia. This new procedure simplifies terminology, streamlines processes, enhances legislative recall powers for the TGA, and ensures clearer communication of recall information for patients, healthcare professionals and device users. These improvements aim to make it easier for suppliers and users to initiate and report product safety actions, enabling the TGA to respond faster to adverse events.
Implications for stakeholders
Mandatory adverse event reporting has long been an obligation of medical device manufacturers, suppliers and sponsors in Australia. However, in many cases, they are unaware that an incident involving their products has occurred. While a product specialist/representative may occasionally be present during a surgical procedure, in most cases, the product supplier will be reliant on healthcare practitioners or hospitals informing them of adverse events.
As such, the new regulations bring the mandatory adverse event reporting obligation to those at the coalface where incidents occur and as they occur. Hospitals must prepare for the upcoming mandatory reporting requirements by establishing robust systems for identifying and reporting adverse events related to medical devices.
Further, an uptick of reporting adverse events involving medical devices can be expected and in turn, more regulatory investigations in relation to medical devices where a spike in adverse reports is observed. The adverse event report data itself will be publicly available and will be a source of information for healthcare professionals in selecting appropriate devices for their patients, thereby enhancing patient care and safety. However, it will also be an additional source of information for lawyers looking to bring claims against healthcare product manufacturers, especially on a mass scale.
New regulations to strengthen medical device patient safety | Therapeutic Goods Administration (TGA)
