Episode Details

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 info@pureglobal.com for tailored support.