Latest / Medical Device Global Market Access
Unlocking the Canadian MedTech Market: Beyond the CE Mark
This episode demystifies the process for CE-marked device manufacturers to obtain a Health Canada Medical Device Establishment Licence (MDEL) for selling in Canada. We break down the crucial differences between an MDEL and a product-specific Medical Device Licence (MDL), clarify who needs to hold an MDEL, and explain why having a CE mark is not a substitute for this essential Canadian requirement. Learn about the key procedural documentation needed for a successful application and the latest guidance from Health Canada. Key Questions: • What is a Health Canada MDEL and how does it differ from…
The skinny
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