May 4th – 8th 2026
Inform Items
- The Minister has approved the TGA’s process for the UDI Consent to Supply. This means that Sponsors can use a streamlined process, with the corresponding reduced fee, for UDI Consent to Supply applications submitted on or after 1 July 2026 (noting that there will be NO refund provision if payment is made before 1 July 2026). Read more on the TGA website.
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The legislative instrument governing emergency import and supply of medical devices has been updated, effective 1 May 2026. The key change is an expansion of scope – section 41HD of the Therapeutic Goods Act 1989 now covers all medical devices and IVDs (previously more limited). The TGA’s web pages have also been updated to clarify that this pathway is for emergency situations only and outline the conditions that approvals may be subject to.
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Indonesia is introducing halal certification requirements for medical devices under its Halal Product Assurance framework, with a phased rollout beginning 17 October 2026 (low-risk devices first, higher-risk devices through to 2039). MTAA members exporting to Indonesia should assess whether their devices involve animal-derived materials, monitor regulatory developments, engage early with local Indonesian representatives, and ensure relevant documentation and certification processes are in place. A TGA web statement with further detail is forthcoming. On Friday 22 May at 2:30pm AEST, the Department of Foreign Affairs and Trade (DFAT), with the support of the Department of Agriculture, Fisheries and Forestry (DAFF), Austrade and the Department of Industry, Science and Resources (DISR), will host a one-hour industry briefing on Indonesia’s import requirements for halal and non-halal products. If you wish to attend, you can register here.
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The TGA is hosting a webinar on Wednesday, 13 May 2026 between 1:00–2:30pm to share outcomes from the consultation on Australian Medical Device Essential Principles – Part 2: Proposed alignment with the European Regulation, including how stakeholder feedback has informed its current thinking. Members who submitted feedback are encouraged to attend. You can register here.
- MTAA is hosting a webinar with Standards Australia on Apr 14 between 11am – 12pm to walk through key developments, how to get involved in committees, and to raise any questions relevant to your work. The invite has been shared with RAF, QAF and RAC. Reach out to lwaheed@mtaa.org.au if you haven’t yet received it.
Action Items
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Predetermined Change Control Plans – Please share your feedback on the clarity of the PCCP guidance consultation via this link. The consultation will be open for 8 weeks, with submissions due by 27 May to be included in MTAA’s response.
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The National SOPs for Clinical Trials (including Teletrials) are under review to align with updated standards — ICH GCP (2025), the National Statement on Ethical Conduct in Human Research (2025), and the Declaration of Helsinki (2024). Following Inter-Governmental Policy Reform Group endorsement in March 2026, sector-wide consultation is now open. Members are encouraged to review the draft and share feedback by COB 15 May to lwaheed@mtaa.org.au
- The International Medical Device Regulators Forum (IMDRF) draft AI Life Cycle Management document has been published for public consultation, with comments closing on July 10, 2026.
MTAA Events
- MTAA RegConnect Summit 2026 (24–25 September, ICC Sydney) — We have opened expressions of interest for members to join our Summit Planning Group, which will help shape the program across key reform areas. This is a great opportunity to have your voice heard and influence the agenda. If you are interested, please email lwaheed@mtaa.org.au.
- MTAA’s Breaking the Silos: Women’s Health MedTech Summit is taking place on 27–28 May at Doltone House Hyde Park, Sydney. With a full agenda of speakers confirmed across two days, this is a not-to-miss event for anyone working in or passionate about women’s health and medical technology. We encourage members to register now and spread the word within your networks!
