Health Canada Medical Device 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 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

Licence Amendments for Class II medical devices, and Licence Amendments (significant changes) 1 for Class III and IV medical devices; Licence Amendment Minor …

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 …

Health Canada Notice on Interpretation of Significant …

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

Jul 28, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the interpretation of …

What's new: Medical devices - Canada.ca

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

Health Canada's Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Informing Canadians about medical device treatment …

Health Canada on Significant Changes: Guidance for …

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 significant changes to medical devices …

Recent Changes to Medical Device Regulations in Canada

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

In last month’s #WebinarWednesday, Canadian regulatory expert Ana Subramanian discussed significant changes occurring this year with Canadian medical device regulations. The two most significant …

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 …

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 …

Guidance Document - Medical Device Licence Renewal …

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

Manufacturers of medical devices that are licensed for sale, in Canada, are required to inform Health Canada each year before November 1 that the information …

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