Episode Details

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 justify the need for a non-compliant device? - Who is eligible to apply for exceptional importation authorization? - What are the common pitfalls to avoid when submitting an application? - How can regulatory teams prepare for urgent shortage situations? - What is the long-term plan required for devices imported under this rule? Sources: - https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/announcements.html How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping them access global markets faster. Our experts in Canada can guide you through complex pathways like the exceptional importation process, ensuring your submissions are comprehensive and meet Health Canada's clarified requirements. We develop efficient regulatory strategies, manage technical dossier submissions, and act as your local representative. By combining in-country expertise with advanced AI technology, we streamline compliance and help you maintain market presence. For support with your market access needs, contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.