Canadian Medical Device Guidance Documents

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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 – Medical devices. For industry information about COVID-19, visit our COVID-19 medical devices section. Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and …

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 Document: Recognition and Use of Standards …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-recognition-use-standards-under-medical-devices-regulations.html

Guidance documents – Medical devices. Guidance on the regulation of medical devices ...

Guidance Document: Guidance for the Labelling of …

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

Guidance Document: Guidance for the Labelling of Medical Devices, not including in vitro diagnostic devices - Appendices for the Labelling of Soft, Decorative, …

Legislation and Guidelines - Medical devices - Canada.ca

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

The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to ensure …

Guidance Document: Management of Applications for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-guidance-2019/document.html

All applications will be subject to an examination for validity of regulatory information for the type of application in question e.g., device risk classification, licence …

Health Canada Guidance on Medical …

https://www.regdesk.co/health-canada-guidance-on-medical-devices/

The Health Canada, the Canadian regulating authority in the sphere of medical devices, issued an interim order and guidance document concerning the …

Health Canada releases new guidance document on …

https://www.smartbiggar.ca/insights/publication/health-canada-releases-new-guidance-document-on-clinical-evidence-requirements-for-medical-devices

On November 15, 2022, Health Canada released a new guidance document, “ Guidance on clinical evidence requirements for medical devices.” In it, …

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