New regulations to strengthen medical device patient safety

Australians who rely on medical devices will benefit from new measures introduced by the Australian Government to enhance the identification and management of device-related safety concerns. 

The Therapeutic Goods Administration (TGA) will now receive clearer identification and more detailed information about devices, allowing it to respond more quickly as and when issues are found. 

Patient safety will be strengthened through a number of key initiatives.

• Hospitals to report medical device adverse events to the TGA

Mandatory reporting of medical device-related injuries or suspected injuries will begin on 21 March 2026 for all public, private and day hospitals. These reports will help the TGA to detect safety issues and prioritise patient safety. To support this, the Australian Commission on Safety and Quality in Health Care will introduce these new reporting requirements into hospital accreditation standards from 2030. 

Professor Anthony Lawler, head of the TGA said, “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”.

• Unique Device Identification 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 start from July 2026. 

When used by healthcare organisations, UDI information can be integrated into hospital systems and patient records, including MyHealth Record, to accurately identify the specific medical device used. 

The TGA will also maintain a public database of UDI information, giving patients access to details about their medical device. 

Professor Robyn Langham, Chief Medical Advisor with 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”. 

• Improved and clearer national recall processes

A stronger and more transparent process for recalling therapeutic goods in Australia has commenced, making it easier for suppliers and users to initiate and report product safety actions, and assisting the TGA in responding quickly and appropriately. 

Key improvements include new and simplified terminology, streamlined processes, enhanced legislative recall powers for the TGA and clearer communication of recall information for patients, healthcare professionals and users. 

These actions reinforce the Government’s commitment to putting patients first when it comes to the safety and performance of medical devices. 

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400