Health Canada Exceptional Importation: Navigating the Updated Forms for Medical Device Shortages

Medical Device Global Market Access · Sep 21, 2026 · 4m

This episode covers Health Canada's September 2, 2026, update to the forms for exceptional importation and sale of medical devices. We discuss the key changes, the criteria for using this pathway to address device shortages, and the practical steps manufacturers must take to prepare and submit successful applications. Key Questions: - What is Health Canada's exceptional importation pathway for medical devices? - What specific changes were made to the application forms on September 2, 2026? - How does a manufacturer prove a medical device shortage exists? - What information is now required to…