Key Achievements
Some of our key highlights and achievements so far include:
- Three consultation papers to inform the development of a UDI system in Australia. Responses to the most recent paper (Detailed considerations for implementing the proposed Australian medical device UDI regulatory framework, July to October 2022) are available on the TGA website.
- Regular webinars since June 2021 covering a variety of UDI-related topics (Unique Device Identification system: Communications and stakeholder engagement)
- Ongoing involvement in the UDI Early Adopters project with Queensland Health and Western Health, Victoria
- Successful rollout of ‘Sandpit’, an early pilot version of the Australian UDI Database (AusUDID), resulted in:
- 422 registered users representing sponsors, manufacturers, software providers and health care professionals
- User feedback being captured and utilised 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)
- Frequent Working Group sessions to specific technical details of the AusUDID such as the submission of data
- Successful integration of AusUDID Pre-Production into the Department of Health and Aged Care’s IT environment
- Launch of the AusUDID Pre-Production environment with registrations being opened to sponsors and manufacturers for early testing of our data submission methods
- Updates to the TGA’s UDI Hub website, including a new ‘About UDI’ page
We look forward to continuing to engage with you in 2023
Keep an eye out for these upcoming events:
- Ongoing enhancements and corrections to the AusUDID Pre-Production environment
- Testing of data submission into the AusUDID Pre-Production environment via Machine-to-Machine (HL7 SPL file format) and the National Product Catalogue (NPC)
- Continuation of UDI Working Groups and webinars
- Hosting face-to-face workshops in June with medical device sponsors and manufacturers in Sydney and Melbourne
- Publication of AusUDID guidance documentation, user guides and other support resources
- Support for sponsors preparing for the AusUDID Voluntary Compliance Period
- Amendments to Medical Devices Regulations in late 2023 that will underpin the Australian UDI System
- Formal launch of AusUDID to coincide with the regulatory changes
- Ongoing updates to the TGA’s UDI Hub webpages
Contact us
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Medical Devices Surveillance Branch |