This reporting requirement will also be embedded into hospital accreditation standards by 2030, in partnership with the Australian Commission on Safety and Quality in Health Care.
The mandatory reporting measure is part of a wider regulatory package designed to improve transparency and traceability in the medical device sector. This includes the rollout of a Unique Device Identification (UDI) system, which will require manufacturers to label devices with barcodes and provide device information to the TGA. The UDI system will help hospitals and clinicians identify and trace devices quickly and accurately—particularly during recalls.
The TGA is also overhauling its product recall process, with clearer classifications, improved communication tools, and stronger legal backing. This aims to make it easier for suppliers and healthcare providers to act rapidly when a device poses a safety risk.
However, the mandatory hospital reporting requirement is seen as one of the most critical tools for improving patient outcomes. It fills a long-standing gap in the national monitoring system by ensuring healthcare providers share vital safety information with regulators.
Hospitals are being encouraged to begin reviewing their internal reporting systems now to prepare for the changes ahead. The TGA will provide guidance and support throughout the transition period.
As medical devices become increasingly common in healthcare—from pacemakers to surgical implants—these reforms represent a significant step toward making device-related harm more visible and preventable across Australia.
What hospitals should be doing now:
- Start reviewing your current incident reporting systems
- Plan for system updates and staff training ahead of the March 2026 start date
- Stay tuned for guidance materials from the TGA.
For more information and timelines, visit the TGA website.
