Canadian Regulatory Affairs Medical Devices

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Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Additional …

Guidance documents – Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing …

Drugs and health products - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products.html

Health Canada's federal regulatory role over drugs and health products; links to adverse reactions, advisories and recalls, legislation, compliance, enforcement, MedEffect, …

Regulatory requirements for importing medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html

Our Medical Devices Directorate (formerly the Medical Devices Bureau) helps to ensure the safety, effectiveness and quality of medical devices sold in Canada. The …

Medical Devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/legislation-guidelines/medical-devices-legislation-guidelines.html

Medical Devices Health Canada applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to …

List of regulatory agencies and foreign jurisdictions

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance/list.html

Dec 23, 2020

Medical device regulations, classification and submissions

https://learn.marsdd.com/article/medical-device-regulations-classification-and-submissions/

For class II, III or IV medical devices, the company must obtain a medical device license issued by Health Canada. To do so, they must submit a device license application and …

Medical Devices Regulatory Affairs Jobs (with Salaries) …

https://ca.indeed.com/Medical-Devices-Regulatory-Affairs-jobs

Regulatory Affairs Associate FluidAI Medical Hybrid remote in Kitchener, ON Estimated at $61.5K–$77.9K a year Full-time Working understanding of the regulatory culture and …

Product Details | RAPS

https://www.raps.org/products/medical-devices-canadian-regulations-30-rac

Discuss the regulatory framework for medical devices in Canada Evaluate the appropriate classification of medical devices Identify the regulatory requirements for an …

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