June 9th – 12th 2026
Inform Items
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The AusUDID Pre-Production and Production environments were upgraded on 9 and 11 June respectively. The release included updates across several components: the AusUDID Online Portal, the Australian UDI Data Dictionary, the M2M HL7 SPL Documentation Suite, the National Product Catalogue submission method, and the Australian UDI Bulk ARTG to UDI Link Template, which has been renamed the Australian UDI Sponsor Link Template.
Minor changes were also made to the Australian UDI Bulk Upload Template, though the previous version remains valid for continued use. Full release notes are available on the TGA’s UDI Resources and Technical Documents page.
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The TGA’s UDI team has bid farewell to Gary Pascoe, their UDI Project Team Lead, who retired this week. Over six years, Gary made a significant contribution to the rollout of UDI in Australia, and was known as a reliable source of both expertise and good humour, within the TGA and across the international regulatory community. The UDI team will continue building on the strong foundations Gary helped establish.
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Several TGA UDI Hub pages have been refreshed, including updated guidance on submitting UDI records via HL7 SPL (now V1.5), the Australian UDI Data Dictionary (now V1.4), and the Bulk Upload page. New additions to the UDI Hub include guidance on using the Pre-Production environment to test UDI submissions, a recording and slide deck from the recent information session for clinical quality registries, and instructions on managing notifications related to UDI Consent to Supply applications. Full details are available on the TGA UDI Hub.
Action Items
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Proposed regulatory amendments to allow Instructions for Use (IFU) for medical devices to be provided in more flexible formats are scheduled for consideration by the Executive Council at its August meeting. If approved, implementation is anticipated between August and September 2026. The eIFU guidance document is currently being updated to reflect the proposed changes. Members are invited to submit feedback on the draft guidance to devicereforms@health.gov.au by COB Friday, 26 June 2026. Please let Laila know if you would like MTAA to submit a response.
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The IMDRF has opened public consultation on its draft Technical Framework for Artificial Intelligence Life Cycle Management (Document N93). Members with feedback are encouraged to share input via RegConnect by 3 July.
- The IMDRF Quality Management Systems Working Group is seeking feedback on its draft Guidance on the Control of Products and Services Obtained from Suppliers, ahead of finalisation for publication. Members are encouraged to share views by 29 June.
