Health Canada Medical Device Guidance Significant Change

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Guidance for the Interpretation of Significant Change of a …

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

Jan 20, 2011

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 …

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

This guidance document applies to the following application types: Licence Applications for Class II, III and IV medical devices; Licence Amendments for Class II …

What's new: Medical devices - Canada.ca

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

For industry information about COVID-19, visit our COVID-19 medical devices section. Files added to the web site are also posted here in the What's New section for three weeks. …

Health Canada Notice on Interpretation of …

https://www.regdesk.co/health-canada-notice-on-interpretation-of-significant-changes/

Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document …

Guidance Document - Medical Device Licence Renewal …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/medical-device-licence-renewal-fees-right-sell-licensed-2019/document.html

Changes to information other than changes to the contact information and notification of discontinuance must be made by submitting the appropriate amendment …

Medical Devices Licence Amendment Minor Change …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/medical-devices-licence-amendment-back-form-guidance-manufacturer.html

Medical Devices Licence Amendment Minor Change Form - Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences Only …

Recent Changes to Medical Device …

https://www.regdesk.co/summary-recent-changes-to-medical-device-regulations-in-canada/

The two most significant changes discussed were new requirements related to foreign risk notification implemented as part of the Protecting Canadians from …

Health Canada on Significant Changes: …

https://www.regdesk.co/health-canada-on-significant-changes-guidance-for-implementation/

Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to …

Medical Devices Licence Amendment Fax-back Form

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/medical-devices-licence-amendment-form-guidance.html

The purpose of the attached fax-back form is to extend the same product line. The purpose of the attached form is to facilitate the approval of device licence amendments where the …

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