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

2 December 2020
The Australian Government will strengthen patient safety through the establishment of a Unique Device Identification (UDI) system for …

Unique Device Identification system: Progress to date

30 June 2021

While Australia has some of the most stringent regulatory requirements in the world, more can be done to strengthen medical device regulation - placing patient safety first.

In 2019 the Government published an Action Plan for Medical Devices , which is a three part strategy to:...

Unique Device Identification system: Benefits to consumers and industry

30 June 2021

Throughout the broader healthcare system, the UDI is intended to be the identifier used in the context of business and clinical transactions. For example, in discharge summaries, patients’ records, registries, clinical notes and records, purchase orders, invoices, inventory maintenance/...

Unique Device Identification system

30 June 2021

This hub brings together information about the Australian Unique Device Identification (UDI) system and will be updated on a regular basis to ensure the content is current and relevant

Unique Device Identification system: Strengthening patient safety

30 June 2021

The Unique Device Identification (UDI) system will be an important way of improving the identification and traceability of medical devices. The UDI will be a key enabler for other reforms designed to improve the effectiveness of pre-market assessments of medical devices and management of post-...

Consultation: Proposed refinements to the regulation of personalised medical devices

7 June 2021
The closing date has been extended and now closes on 14 July

Presentation: EU Medical Device Regulation: Implications for the TGA and Australia

18 May 2021

EU Medical Device Regulation changes and the implications for the TGA and Australia

Reclassification of medical devices that administer medicines or biologicals by inhalation

22 November 2021
Updated guidance to reflect new amendments made to the regulations.

Reclassification of active implantable medical devices (AIMD)

29 March 2022

This guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 active implantable medical devices will be required to be reclassified from Class AIMD to Class III.

Reclassification of active medical devices for therapy with a diagnostic function

12 May 2021

This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 active medical devices for therapy with a diagnostic function will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

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