Access the United States Market: Introduction to U.S. FDA Medical Device Regulations Join us as we break down the fundamentals of medical device regulation in the United States. Learn how the FDA classifies devices, what pathways exist for market entry, and the compliance obligations every manufacturer must understand. From registration and labeling to UDI compliance, this session is ideal for medical device companies looking to enter or expand in the U.S. market.

Dr Kate Waterworth (AUT) and Dr Sally Britnell (AUT) will deliver keynote talks, followed by a hybrid discussion.

Join us in Christchurch for the Digital Health AI Summit, a one-day event bringing together leaders, clinicians, researchers, policy makers, technologists and innovators to explore the theme of ‘security and equity by design’.