In Canada, medical devices must undergo a regulatory review and clearance process before they can be sold on the market. Health Canada is the government agency responsible for regulating and approving medical devices. The regulatory process for medical devices in Canada involves obtaining a medical device license (MDL) or medical device establishment license (MDEL) depending on the device classification. Here are the major steps in obtaining Health Canada clearance for medical devices:
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Device Classification- Risk based classification from Class I to IV. Class I devices are considered low-risk, while Class IV devices are high-risk
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License Types – MDL and MDEL
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Preparation of regulatory submission application
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QMS- ISO 13485, MDSAP certification
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Review by Health Canada
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Review Timeline: The time takes for Health Canada to review a submission can vary based on the risk classification of the device. Lower risk device may have shorter review timeline than high-risk device
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License Issuance