Why do medical devices have different classifications?

February 16, 2023

Medical devices vary greatly and each device is given one of four classifications by Health Canada based on the anticipated risk to a person’s health and safety. Class I medical devices (a wheelchair) are low risk, while Class IV medical devices (a defibrillator) pose the highest risks.

Class II and higher devices must obtain a medical devices licence before they can be sold in Canada. A second type of licensing (medical device establishment licence) is required for companies to import (Class I to IV), distribute (Class I to IV) or manufacture (Class I) medical devices.

If a medical device caused you harm regardless of its classification, our medical malpractice lawyers can help you look into it. We're happy to talk through your situation at no cost. And you'll never be asked to pay anything before your case is resolved.

Why do medical devices have different classifications?

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