While Australia has some of the most stringent regulatory requirements in the world, more can be done to strengthen medical device regulation and to improve patient safety.
In 2019, the Australian Government published an Action Plan for Medical Devices, a three-part strategy to:
- improve processes to get new devices on the Australian market
- 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. Implementing an Australian UDI System 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 Therapeutic Goods Administration (TGA) is continuing to work on the implementation of the Australian UDI System, and establishing the Australian Unique Device Identification Database (AusUDID).
The Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 introduced on 8 December 2020, sought to make changes to the Therapeutic Goods Act 1989, allowing the establishment of the AusUDID. Royal Assent was received on 19 February 2021.
Feedback has been sought to inform the planning and design of the UDI implementation through three public consultations:
- The first, Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia (January 2019) explored the feasibility of introducing a 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 (September 2020) reviewed aspects of UDI related to its use in the broader healthcare system.
- The third, Detailed considerations for implementing the proposed Australian medical device UDI regulatory framework (October 2022) has helped inform the proposed regulatory framework for the Australian UDI System and implementation and operation of the AusUDID.
The TGA implemented a ‘Sandpit’ version of the Australian UDI Database (AusUDID) between July 2022 and the end of January 2023 for all stakeholders to use and provide feedback on the usability and design of the future AusUDID.
What is next
The TGA has been working towards supporting sponsors to voluntarily comply with the Unique Device Identification requirements from 1 July 2023.
Due to the number of government Bills and Budget measures being drafted, the UDI regulations will not be in place by July 2023, therefore the voluntary compliance date will be deferred.
The UDI team will provide updated advice on revised timeframes for voluntary and mandatory compliance dates when known.
Contact us
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Medical Devices Surveillance Branch |