Medical Device Evaluation Canada

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Medical Devices Directorate – Health Canada - Canada.ca

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/medical-devices-directorate.html

The Medical Devices Directorate (MDD) is Canada's regulator of medical devices for human use. Before authorizing the sale of a medical device in Canada, we verify that the device meets the safety, effectiveness and quality requirements of the Food and Drugs Act and its Regulations. We also work collaboratively … See more

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 …

Guidance on clinical evidence requirements for medical …

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

The Medical Devices Regulations (Regulations) use a risk-based approach to regulating products within their scope. The safety and effectiveness evidence …

Service Standards for Medical Device Submission …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/service-standards-high-volume-regulatory-authorizations/service-standards-medical-device-submission-evaluations-under-medical-device-regulations.html

The evaluation of medical device submissions is a service with a high volume of regulatory ...

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 …

About medical devices - Canada.ca

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

In Canada, medical devices are grouped into 4 classes based on the expected level of risk to a person's health and safety. Class I medical devices (e.g., a thermometer) pose the …

Clinical Evaluation for Medical Devices | BSI Canada

https://www.bsigroup.com/en-CA/Medical-Devices/Training/Clinical-Evaluation-for-Medical-Devices/

Clinical Evaluation for Medical Devices | BSI Canada Medical Devices Clinical Evaluation for Medical Devices SHARE Medical Devices Clinical Evaluation for …

Medical device licensing - Canada.ca

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/medical-device-licensing.html

Medical device licensing - Canada.ca Canada.ca Health Drug and health products Licensing, authorizing and manufacturing drug and health products Medical …

Guidance on Medical Device Compliance and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-medical-device-compliance-enforcement-0073.html

the requirement for device licensing (DL) or authorization (sections 26, 70 or 80), the requirement for establishment licensing (EL) (section 44), stop sale for class I …

Medical device inspections - drug-inspections.canada.ca

https://www.drug-inspections.canada.ca/md/index-en.html

Medical device inspections Medical device inspections Medical devices made in Canada or abroad must meet high safety and quality standards before being sold to Canadians. …

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