Canadian Regulatory Framework for Software-based Medical Devices and Emerging Technologies

The digital health space has introduced new and innovative technologies in the last few years that have posed significant challenges to our current regulatory frameworks. These products include software-based medical devices such as SaMD and AI/ML-enabled devices, which make up the new digital health environment. To keep pace with digital innovation, regulators around the world have worked towards developing a harmonized approach to regulating these technologies from establishing cybersecurity principles at the international level to consolidating machine learning principles to guide development of AI/ML-enabled technologies. The regulation of software and emerging technologies has gained much attention around the world. What is Canada’s framework for regulating the digital health space? This question has confounded manufacturers worldwide as well as domestic Canadian MedTech organizations as they seek to enter the Canadian market. This session is intended to provide an overview of the regulatory landscape in Canada with respect to regulation of innovative technologies and clarify the misconceptions around the Canadian regulatory framework. This session is focused on the regulation of software-based products and emerging technologies in Canada. At the end of the session, participants will gain not only an overview of the current regulatory landscape in Canada with respect to digital health technologies but also an understanding of the Canadian MedTech business environment and the opportunities to bring innovations to a growing MedTech market.