July 20th – 24th 2026
Inform Items
- RegConnect Summit 2026 – The program is coming together beautifully, with 15+ sessions spanning EU MDR, TGA Reforms, SaMD/AI, post-market surveillance, IMDRF, and more, alongside an outstanding lineup of international regulators from the MHRA, FDA, EU Commission, HSA and MDS. Don’t miss the chance to lock in your seats and experience two days of world-class regulatory insight at ICC Sydney, 24–25 September.
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UDI Implementation Forum – Following a suggestion from the RAC, a UDI Implementation Discussion Forum has been created under the MTAA Members Group on RegConnect, providing a space for members to discuss challenges and share experiences with UDI implementation. Members are encouraged to post any questions or issues they’re facing.
Action Items
- Remanufacturing and Reprocessing Working Group – MTAA has established a Remanufacturing and Reprocessing Working Group, as the TGA is now also beginning work in this space. If you would like to participate in the group as well, please join via the platform. The TGA has also asked for member input on the challenges and limitations being faced with the remanufacturing and reprocessing of medical devices, including practical, regulatory, or commercial examples and relevant international approaches or precedents – please share any input with Laila by COB 19Aug.
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TGA Advertising Code Consultation – The consultation is open on RegConnect under the Consultations Hub, with member input due by COB 21 August 2026. Kindly share feedback via the platform, or use the Industry Comments section to discuss with peers ahead of the deadline.
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Standards Australia Committee Seats, Call for Members – Please reach out to Laila if you would like to fill any of MTAA’s 10 seats across the below Standards Australia technical committees currently open for MTAA member representatives:
- HE-003 – Medical Electrical Equipment
- HE-030 – Biological and Clinical Evaluation of Medical Devices
- SF-001 – Occupational Health & Safety Management
- HE-012 – Surgical Implants
- HE-032 – Biotechnology
- MS-024 – Optics and Ophthalmics
- TE-016 – Personal Alarm Systems
- MB-027 – Ageing Societies
- HE-023 – Processing of Medical and Surgical Instruments
If you are interested in filling one of the above 10 seats, please reach out to Laila.
