July 27th – 31st 2026

Electronic Instructions for Use (eIFUs) – Following a 28 July meeting with industry on the draft eIFU guidance and proposed amendments, differing views emerged between industry and the TGA on how the current framework operates and the intended effect of the changes. As a result, the proposed amendments won’t proceed further while these matters are worked through.

MDSAP RAC – 2026 Forum Outcome Statement – The MDSAP Regulatory Authority Council has released the outcome statement from the 2026 MDSAP Forum, hosted by Japan’s MHLW and PMDA in Kyoto from 15 to 19 June 2026, bringing together representatives from Auditing Organisations, Affiliate and Observer countries, RAC members and industry representatives. The statement is attached.

RegConnect Summit 2026 – The program continues to take shape, with 15+ sessions covering EU MDR, TGA reforms, SaMD/AI, post-market surveillance, IMDRF, and more, plus regulators from the MHRA, HealthCanada, USFDA, EU Commission, HSA and MDS. And there’s more to celebrate at the Summit this year – this is your moment RA, QA and Clinical professionals! We are thrilled to launch the inaugural RegConnect Regulatory Industry Awards, celebrating the people driving excellence in the sector, across five categories. Nominations open Monday 3 August, winners announced live at the Summit. More details soon, so start thinking about who deserves a nod!

Remanufacturing and Reprocessing Working Group – MTAA’s new 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.

UDI Discussion Forum – The UDI Implementation Discussion Forum remains open for members to post questions or share experiences.