April 28th – May 1st 2026

Inform Items

The TGA has published its position on the UDI Consent to Supply process. From 1 July 2026, sponsors of Class IIb and Class III medical devices will be able to use a streamlined application process with corresponding fees. Read more on the TGA website.
From 1 May 2026, the case management team are providing sponsors with monthly status updates for each application audit. This aims to assist sponsors with timely information about the progress of their applications in the audit process.
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. Register here.
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!
The UNSW Biomedical Engineering Students Society (BESS) is hosting its annual Careers Night on 29 June 2026, connecting students with professionals across biomedical and related engineering fields. Members are invited to participate, whether through a panel discussion, networking, or representing your organisation. To register your interest, sign up here.
Alisa Greyze, an Honours student in Biomedical Engineering at the University of Sydney, is researching how post-market surveillance (PMS) requirements differ across major regulatory frameworks, with the aim of developing a harmonised international PMS model. She is inviting regulatory affairs professionals to participate in a short online survey (10–15 minutes), with an optional follow-up interview. Interested members should contact Alisa directly at agre5388@uni.sydney.edu.au to receive a consent form and survey link.
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

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.
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.