Why do medical devices have different classifications?
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.