Hello Anon,
If the intended refrigerator as a medical device is not a medical device in Canada, then it can be sold and distributed as any other good. Selling of goods may require additional requirements non-medical device related such as importation, electrical safety, hazardous material, etc. If you want the refrigerator intended to be sold as a medical device in Canada, this might be something to speak directly with Health Canada about
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/about-medical-devices.html. There are a couple guidance documents and reaching out to Health Canada directly can be helpful as they are quite responsive. Like most products going into the medical device area, the determination depends largely on the claims being made, intended purpose, and whether the product can fit in the definition of a medical device.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-Dec-2022 09:05
From: Anonymous Member
Subject: Canada - Medical refrigerator
This message was posted by a user wishing to remain anonymous
Hi RAPS group,
We are looking to sell our Medical refrigerators to Canada, However in Canada these device don't qualify as Medical device.
Can someone help us to understand the regulations required to sell the device into the Canadian market.