Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
Implementation dates in Australia
We have been working towards finalising the UDI regulations and engaging with sponsors on the Unique Device Identification requirements.
Implementation timeframes and compliance dates will be published as soon as they are confirmed.
Upcoming events
We continue to engage with sponsors, manufacturers, consumers, and healthcare professionals via a series of UDI webinars and Working Groups.
To find out more, contact the UDI Support Team at: udi@health.gov.au
Progress to date
Key highlights and achievements so far include:
- Three consultation papers to inform the development of UDI in Australia. Responses to the paper (Detailed considerations for implementing the proposed Australian medical device UDI regulatory framework, July to October 2022) are available on our consultation hub: Published responses for UDI consultation paper 3: Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework
- Various UDI webinars, covering diverse UDI-related topics
- Frequent Technical Working Group sessions to collaboratively work through specific technical details of the AusUDID
- Ongoing involvement in the UDI Early Adopters project with Queensland Health, and Western Health, Victoria and the Australian Commission on Safety and Quality in Health Care
- Successful rollout of ‘Sandpit’, an early pilot version of the Australian UDI Database (AusUDID), which resulted in:
- 422 registered users representing sponsors, manufacturers, software providers and health care professionals
- Capture of user feedback used to guide system enhancements
- Testing data submission methods including:
- Bulk upload via Microsoft Excel files
- Machine-to-Machine (M2M) upload via HL7 SPL files
- Data transmission via the National Product Catalogue (NPC)
- Launch of the AusUDID Pre-Production environment with registrations being opened to sponsors and manufacturers for early testing of data submission methods.
Next steps
- Testing AusUDID Pre-Production environment including sponsors submitting data via Machine-to-Machine (HL7 SPL file format) and the National Product Catalogue (NPC)
- Publication of AusUDID guidance documentation, user guides and other support resources
- Finalisation of the amendments to the Medical Device Regulations and formal launch of the AusUDID database
- Continuing to host UDI webinars and UDI Technical Working Group meetings.
Contact us
| Email: | UDI@health.gov.au |
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| Phone: |
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| Post: | Devices Reforms Taskforce Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia |