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 product-specific Medical Device Licence?
• Who is required to hold a Medical Device Establishment Licence?
• As a foreign manufacturer, does my company need an MDEL to sell in Canada?
• What role does the Canadian importer play in the regulatory process?
• Does Canada require a formal in-country representative or authorized representative?
• What are the annual renewal deadlines for each type of license?
• What is the function of a regulatory correspondent?
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