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:

• improve how new devices get on the market in Australia
• strengthen monitoring and follow up of devices already in use
• provide more information to patients about the devices they use

The Action Plan provides an overview of the current regulatory system, what actions are proposed and the timeframes for these.  The UDI forms part of this strategy and underpins activities to strengthen monitoring and follow up of devices already in use.

What we have done so far

The Australian Government has determined that the Therapeutic Goods Administration (TGA) will establish and maintain the Australian Unique Device Identification database (AusUDID).

Feedback has been sought to inform the planning and design of the UDI implementation through two consultations:

• The first Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia was published in January 2019 and explored the feasibility of introducing the UDI system in Australia, including options for development of the UDI database.
• The second Exploring options for the introduction of an Australian Unique Device Identification (UDI) system was published in September 2020 and explored aspects of UDI related to its use in the broader healthcare system.

The TGA obtained Australian Government approval to invest $7.7 million from its cash reserves to establish the Australian UDI database.

The Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 was introduced on 8 December 2020, seeking to make changes to the Therapeutic Goods Act 1989, allowing the establishment of the AusUDID. Royal Assent was received on 19 February 2021.

Implementation timeframe

The TGA is in the early planning stages for the Australian implementation and has not yet defined the new regulations, regulatory dates or the transition approach. 

We understand that many manufacturers supply to multiple markets and are preparing to meet the new European Union (EU) regulations, and Australia does not plan to implement before the EU dates.