medical device compliance

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On this page we provide links to useful medical device regulatory information and guidance in major jurisdictions.

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Canada

Health Canada - Medical Devices Main Page - Application information, licences, guidance, fees and more


Medical Devices Regulation SOR/98-282 - Canada's governing medical device regulation


Understanding How Medical Devices are Regulated in Canada - An e-learning tool

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USA

 FDA - Device Advice -  Comprehensive Regulatory Assistance