Australian Government to establish a Unique Device Identification system for medical devices

The Australian Government will strengthen patient safety through the establishment of a Unique Device Identification (UDI) system for medical devices. The system is an Australian first and will allow tracking and tracing of medical devices that have been implanted in patients. It will enhance the ability for doctors to notify patients quickly if there is a safety issue with a medical device and strengthen Australia's post-market medical device adverse event system.

The UDI system is a key pillar of the Government's response to the Senate Inquiry into The number of women in Australia who have had transvaginal mesh implants and related matters. It underpins the response to four recommendations made by the Senate Committee, relating to post-market surveillance and monitoring throughout the healthcare system.

Implementing a UDI system protects patient safety and allows for a quick response to any safety issues that may arise with implanted devices.

The Government will invest $7.7 million from 2020–21 to 2023–24 through the Therapeutic Goods Administration to support this initiative.