24-25 September 2026
MTAA RegConnect Summit 2026 Program
8.30am
Registration opens | Coffee Cart opens
9.00 - 9.10am
10 min
Introduction - Welcome to Country
Uncle Michael West from Metropolitan Local Aboriginal Land Council.
A member of the Stolen Generations.
Born raised and lived his whole life in the Sydney community.
Cultural Educator and practicing artist.
First Aboriginal person in computing science.
Use what you think will fit in form below contextually.
Michael has had a variety of previous roles
• Director – NSW Indigenous Chamber of Commerce
• Director – Australian Communications Consumer Action Network (ACCAN)
• Co-Chair – National Sorry Day Committee
• Delegate – National Congress of Australia’s First Peoples
• Aboriginal & Torres Strait Islander Advisory Committee to the Board of
Headspace
• Aboriginal & Torres Strait Islander Advisory Group Australian Curriculum
Assessment Reporting Authority
• Cultural Advisor Tedx Sydney
9.10 - 9.20am
10 min
Welcome and Official Opening
9.20 - 9.30am
10 min
1
Beyond the Paperwork: A Lived Experience
9.30 - 10.30am
60 min
2
IMDRF Priorities: Setting the Global Agenda
10.30 - 11.00am (30min)
Morning Tea
11.00am - 12.00pm
60 min
3
EU MDR: State of Play
12.25 - 12.55pm
30 min
4
EU MDR Meets Australia: Managing Two Systems
1.00 - 1.45pm (45 min)
Lunch
1.30 - 2.30pm
60 min
5
Signals & Systems: Post-Market Surveillance in Practice
A/Prof Fiona Brownfoot (MBBS, FRANZCOG, PhD) is a clinician scientist, an obstetrician at the Mercy Hospital for Women and the Epworth Freemasons and a laboratory trained scientist at The University of Melbourne. She co-founded start-up Kali Healthcare and is the CMO and COO. Kali Healthcare is focused on delivering a fetal monitoring platform, wearable device with AI diagnostics to better detect pregnancy complications and bring more mothers and babies safely home. She has authored over 85 publications in journals including BMJ, Nature’s npj Digital Medicine, American journal of Obstetrics and Gynaecology among others and has been the CI on research grants over $13 million and commercial grants over $2.6 million. She has received national and international awards for her work and given numerous invited presentations.
2.35 - 3.05pm
30 min
6
Sustainability by Design: ESG Meets MedTech
3.10 - 3.30pm (20 min)
Afternoon Tea
3.30 - 4.10pm
40 min
7
The Art of Regulatory Dialogue
4.10 - 4.25pm
15 min
8
The Human Factor: Why Usability Matters More Than Ever
4.25 - 5.00pm
35 min
9
The Fine Print: Advertising Compliance in Focus
5.00 - 5.15pm
15 min
Break
5.15 - 6.15pm
Welcome Reception
8.30am
Registration Opens
Registration Opens
9.00 - 9.05am
5 min
Welcome to Day 2
9.05 - 10.05am
60 min
10
Inside TGA Reform
Australia's regulatory landscape is undergoing significant reform, with TGA implementing changes across pre-market, post-market, and conformity assessment pathways. This session brings together TGA representatives to take stock of what has changed, what is still in progress, and how sponsors and manufacturers should be adapting their regulatory strategies - with a dedicated segment on UDI implementation, comparing where Australia stands against international approaches and exploring both regulator and industry perspectives on the path ahead.
10.05 - 10.55am
50 min
11
Lessons Learnt from Around the Globe: The World's Best Ideas #1
A high-level international regulatory update from attending regulators, each sharing examples of successful regulatory initiatives from their jurisdiction over the past year.
10.55 - 11.20am (25 min)
Morning Tea
11.20am - 12.10pm
50 min
12
Lessons Learnt from Around the Globe: The World's Best Ideas #2
A high-level international regulatory update from attending regulators, each sharing examples of successful regulatory initiatives from their jurisdiction over the past year.
12.10 - 12.45pm
35 min
13
Innovation's Front Door: Priority Pathways
This session maps the priority and expedited access pathways available across key jurisdictions, and examines what qualifies a product for these designations, helping attendees understand where opportunity exists and how to build a compelling case.
12.45 - 1.30pm (45 min)
Lunch
1.30 - 2.15pm
45 min
14
Certifying at the Speed of Software
As software and AI increasingly define the medical device landscape, certifying these products demands a fundamentally different approach to conformity assessment. This session explores what it takes to certify SaMD and AI as a Medical Device, the regulatory and clinical evidence considerations unique to iterative, continuously-updating AI models, and how a certification process built specifically for software differs from traditional device pathways.
2.15 - 3.00pm
45 min
15
AI at Work: Reshaping the Regulatory Lifecycle
3.10 - 3.30pm (20 min)
Afternoon Tea
3.30 - 4.15pm
45 min
16
MDSAP: State of the Union
4.20 - 4.50pm
30 min
17
Straight to the Source: TGA Q&A Panel
4.50 - 5.00pm
10 min
Break
5.00 - 6.00pm
Closing Reception
Day 2 End
