August 10th – 14th 2026
Inform Items
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AusUDID Patch Release – On 6 August 2026, several enhancements and fixes were released to the AusUDID Production environment, including improvements to download functionality and performance, updates to search and browse results, and fixes to Sponsor Link Template publishing behaviour. Users can now view or download up to 5,000 UDI records at a time.
- eIFUs – Following a recent discussion with RegTech representatives on the upcoming eIFU guidance and proposed regulatory amendments, the TGA has developed the attached position statement on the proposed Instructions for Use amendments. They will continue to consider feedback on the provision of eIFUs for medical devices and will provide a further update at the next RegTech meeting.
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RegConnect Summit 2026 – The program keeps growing, now with 19+ sessions covering EU MDR, TGA reforms, SaMD/AI, post-market surveillance, IMDRF and more, alongside regulators from the MHRA, Health Canada, US FDA, EU Commission, HSA and MDA. We’re also excited to announce Scarlet, the world’s only Notified Body specialised in SaMD/AI, as a sponsor and speaker at this year’s Summit. And a reminder that nominations for the inaugural RegConnect Regulatory Industry Awards are open now, so if you know someone driving excellence across RA, QA or Clinical, get your nomination in ASAP before the judging kicks off in September!
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Planned outage for medical device adverse event reporting – Please be advised that updates of the Department’s IT systems is scheduled from 10:00 am to 11:00 pm AEST on Sunday 30 August. During this time, access to the Medical Device Adverse Event Reporting System may experience disruptions or may not be available. The TGA encourages you to plan your activities accordingly to mitigate any inconvenience. Should you require urgent access to the system, or if you have concerns following the update period, please contact the support team at IRIS@health.gov.au for assistance.
- TGA Health Equity Paper – Sharing on behalf of the TGA an update on their work to incorporate health equity considerations (including sex and gender) into therapeutic goods regulatory processes. This is for noting only.
Action Items
- TGA Information Sharing Consultation – The TGA is undertaking a public consultation on proposed changes to the information we share about the safety, quality and performance of medical devices. These changes align with the intent of An Action Plan for Medical Devices and the requirements set out in WHO’s Global Benchmarking Framework. The proposed changes intend to provide more information to the public after post-market reviews or investigations of a medical device, particularly where findings relate to the safety, quality, performance or use of a medical device. The consultation seeks feedback on:
- if the TGA should share information about medical devices involved in a post-market review or investigation, and
- what types of information should be shared when a post-market review or investigation is being undertaken.
The consultation is open for MTAA member input on RegConnect till 25 September 2026.
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Remanufacturing and Reprocessing Working Group – MTAA’s working group is active as the TGA begins work in this space. Join via the platform if interested, and share any input on remanufacturing/reprocessing challenges, examples, or international precedents with Laila.
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UDI Discussion Forum – The UDI Implementation Discussion Forum remains open for members to post questions or share experiences.
- TGA Advertising Code Consultation – open on RegConnect, with member input due by COB 21 August. Share feedback via the platform.
