MEDICAL DEVICE RESOURCES

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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Medical devices for uses related to COVID-19 - List of authorized COVID-19-related devices 

USA

FDA - Device Advice -  Comprehensive Regulatory Assistance 

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FDA Guidance Documents - Searchable database for medical devices and radiation-emitting products 

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Medical Devices and the COVID-19 Pandemic - Guidance and information about diagnostic tests, ventilators, PPE, Emergency Use Authorizations related to COVID-19

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Europe 

EU In-vitro Diagnostics Regulation (IVDR) 2017/746

EU Medical Device Regulation (MDR) 2017/745 

MD Law - Guidance on MDR Compliance

International Medical Device Regulators Forum (IMDRF) 

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EU response to COVID-19 - Includes links to members states COVID-19 guidance