On 30 June 2025, the Therapeutic Goods Administration (TGA) announced new regulatory measures aimed at strengthening the identification, traceability, and safety oversight of medical devices in Australia. These updates will support faster detection of safety issues and reinforce protections for patients across healthcare settings.
Key Initiatives Introduced
The reforms focus on three major areas of safety enhancement:
1) Mandatory Hospital Reporting of Device Adverse Events
Beginning 21 March 2026, all public, private, and day hospitals will be required to report medical device-related injuries or suspected injuries to the TGA. This early warning system will significantly improve the TGA’s ability to act swiftly on potential safety concerns.
These mandatory reporting obligations will be embedded into hospital accreditation standards starting from 2030, as coordinated by the Australian Commission on Safety and Quality in Health Care.
2) Implementation of a Unique Device Identification (UDI) System
Medical device manufacturers will soon need to:
- Use barcodes (UDI) on all product packaging and labels
- Submit device identification data to the TGA
This requirement becomes mandatory for implanted devices from July 2026.
Healthcare providers will be able to integrate UDI data into hospital systems and patient records, including MyHealth Record, helping to:
- Accurately trace devices used in patients
- Empower patients with access to detailed device information via a public UDI database
3) Improved National Recall Procedures
The TGA has implemented a more transparent and efficient recall process, including:
- New, simplified recall terminology
- Streamlined procedures for suppliers and users
- Stronger legislative recall powers
- Clearer communication for patients, healthcare professionals and users
These reforms collectively represent a major regulatory shift aimed at prioritizing patient safety, transparency, and real-time responsiveness in Australia’s medical device oversight system.
Official Source: New regulations to strengthen medical device patient safety
Published by TGA on 30 June 2025
