Regulatory Open Forum

Hello Anon

Yes, if you want to distribute medical devices in Canada, an establishment licence (MDEL) is required. Guidance: 
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016.html

If the devices fall in Canada's class 2, 3, or 4, a device licence (MDL) is also required. Note that the US FDA device classification scheme is different from Canada's. Canada guidance:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html


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Anne LeBlanc
United States
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Original Message:
Sent: 23-Aug-2022 12:57
From: Susan Starmer
Subject: Distributor License in Canada

Hello,

If a company is distributing FDA Class II devices into Canada, does Canada require the Distributor to obtain a license? The company is acting solely as a distributor, not the manufacturer of the devices, and wants to distribute to hospitals and clinics. Thank you in advance for any guidance you could provide!