340 Global Regulators, Health Authorities and Industry Partners Gather in Sydney for Australia Regulatory Device Summit 2025
Sydney, AU — 21 July 2025 —The Regulatory Affairs Professionals Society (RAPS) and the Medical Technology Association of Australia (MTAA) just concluded the Australia Regulatory Device Summit 2025, held at the ICC Sydney 17-18 July. The Summit, which attracted 340 attendees from 12 countries and 5 continents, addressed Australian regulatory reforms and international harmonisation. The event also provided participants with insights and access to representatives from organisations such as ANVISA (Brazil), HSA (Singapore), PMDA (Japan), FDA (U.S.), TGA (Australia), and the European Commission, as well as other healthcare leaders and MedTech professionals.
“Our landmark MTAA/RAPS partnership is the first collaboration of its kind in Australia,” said MTAA CEO Ian Burgess. “This year’s Summit brought together an extraordinary group of experts and professionals united by a shared goal— improving regulatory systems to support innovation, safety, access and ultimately better patient outcomes. It also reinforced the importance of a strong, connected regulatory community; one that engages openly with regulators, shares insights across borders, and drives improvements in both policy and practice.”
The programme featured 48 expert presenters across 13 in-depth sessions throughout the two days. Discussion topics included:
- Global Regulators Down Under: A Taste of IMDRF in Australia
- U.S. Regulations & AU Reliance
- Cleared for Launch: UDI Takes off in Australia
- Australian Regulatory Reforms: Pre and Post-Market
- New Zealand Regulations
- MedTech Match: What Role Fits You Best? (Career Development Session for Students)
- MDR State of Play
- All Things AI: A 360° Perspective on Artificial Intelligence in Health
- Global and Local Regulatory Pathways for Australian Manufacturers
- Global Insights, Local Impact: The Evolving Role of the MDSAP Program
- Talking to Decision Makers: What to Say and How to Say It
- Environmental Sustainability and Regulatory Implications
- Vision 2030 Fireside Chat – A Shared Future for the Australian MedTech Regulatory Landscape
Amy Fisher, RAPS Vice President, Engagement, Marketing & Member Development, commented that “it was exciting to see the community come together with such enthusiasm and engagement. From in-depth presentations and insightful audience questions to high-quality networking and hallway conversations, there was certainly a buzz that seemed to spark new ideas, innovations and collaboration opportunities. RAPS was thrilled to work with MTAA to offer a distinct forum for these interactions to happen.”
For more information about the Australia Regulatory Device Summit 2025, visit www.ausregsummit.org.
