MEDICAL DEVICE RESOURCES

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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

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

 

Health Canada’s Health Product Highlights Report 2021 - Annual report covering drugs, health products, medical devices and  lists of products approved in 2021

Health Canada Action Plan on Medical Devices - Health Canada's action plan to modernize the medical device compliance program

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USA

FDA - Device Advice -  Comprehensive Regulatory Assistance 

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

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