Unlocking the Canadian MedTech Market: Beyond the CE Mark
Medical Device Global Market Access · Pure Global
August 28, 20253m 30s
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Show Notes
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 an MDL?
• If our device has a CE mark, do we still need an MDEL to sell in Canada?
• Who is legally required to hold an MDEL?
• Can a foreign manufacturer or distributor apply for an MDEL directly?
• What are the core procedural requirements for a successful MDEL application?
• How does the new GUI-0016 guidance, effective December 2024, impact applicants?
• Does having an MDSAP certificate exempt a company from needing an MDEL?
• What activities are covered by a Medical Device Establishment Licence?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.