Australia Regulatory Device Summit 2025

Medical Technology Association of Australia (MTAA) and the Regulatory Affairs Professionals Society (RAPS) are proud to announce their first-ever collaboration for the Australia Regulatory Device Summit 2025. This landmark event will bring together regulatory professionals, global health authorities, and industry leaders to address critical challenges and opportunities in medical device regulation. Building on the success of MTAA’s RegConnect24 Conference.

RAPS and MTAA Partnership

MTAA and the Regulatory Affairs Professionals Society (RAPS) are combining their 94+ years of expertise to deliver one of the most significant regulatory events on the Australian MedTech calendar. Uniting RAPS’ global regulatory insights with MTAA’s leadership in the Australian industry, the Australia Regulatory Device Summit 2025 will offer attendees unparalleled access to expert knowledge—featuring perspectives from top local and international regulators, healthcare leaders, and MedTech professionals.

Extensive Regulatory Program

This two-day summit will bring together regulatory leaders, key opinion leaders with Therapeutic Goods Administration (TGA) and international regulatory bodies to explore:

• Domestic Regulatory Updates: Recent reforms, digital transformation, and UDI implementation.
• Global Perspectives: European MDR, US regulations, and AI governance frameworks.
• Practical Insights: Real-world evidence, audit frameworks, and leadership development for regulatory professionals.
• Actionable strategies to navigate evolving requirements and drive innovation in MedTech.

New for 2025

The event will bring together overseas regulators offering an international perspective on vital issues such as:

• European regulations (MDR)
• Global regulations in AI
• US regulations
• IMDRF
• Leadership skills for regulatory professionals

This event is distinctly designed to foster open discussions and idea exchange between the Therapeutic Goods Administration (TGA), global health authorities and the regulatory professional community. If you are a key stakeholder focused on medical devices and medical technology (MedTech), you can't afford to miss the Australia Regulatory Device Summit 2025!

Sponsorship

Visit the sponsorship event page to learn more.

Early Bird Registration

Early Bird registrations close 30 May 2025 at 5:00pm AEST

• Members: $1,400 incl. GST per person
• Non-Members: $1,950 incl. GST per person
• Government/Non-Profit/Academia: $1,400 incl. GST per person
• TGA: $0

Full Registration

Registration from 31 May 2025.

• Members: $1,750 incl. GST per person
• Non-Members: $2,300 incl. GST per person
• Govenrment/Non-Profit/Academia: $1,750 incl. GST per person
• TGA: $0

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