Canada's MedTech Entry Pass: MDL vs. MDEL Explained

Medical Device Global Market Access · Oct 10, 2025 · 3m

This episode demystifies Canada's dual-licensing system for medical devices. We clarify the critical differences between a product-specific Medical Device Licence (MDL) for Class II-IV devices and a company-specific Medical Device Establishment Licence (MDEL) required for Class I manufacturers, importers, and distributors. Learn who needs which license, the role of the importer, and why the concept of a regulatory correspondent is vital, even without a formal in-country representative requirement. • What is the difference between a Canadian MDL and an MDEL? • Which device classes require a…