Health Canada Medical Device Licence Amendment

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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; Medical Devices Licence Amendment Fax-back Form - Guidance For Non …

Medical device application and report forms - Canada.ca

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

Application for a Medical Device Licence Amendment for a Private Label Medical Device; New Class III Medical Device Licence Application Form; Application …

Application for a Medical Device Licence Amendment for …

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

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

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

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

Class III Medical Device Licence Amendment Application …

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

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

Guidance Document: How to Complete the Application …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence-amendment-private-label.html

This guidance applies to applications submitted by private label manufacturers for new device licences and amendments to existing device licences for Class II, III …

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 …

Class II medical device licence amendment …

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/applic-demande/form/md_licam_im_demmhom_cla2-eng.pdf

Name of device licence being amended Licence number to be amended (provide the latest valid licence number(s)) Manufacturer information (as it appears on the label and the …

Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

32 - Application for a Medical Device Licence 32.1 - Quality Management System Certificate 33 - Foreign Manufacturers 34 - Application for a Medical Device Licence …

Health Canada Notice on Interpretation of …

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

According to the guidance, a medical device manufacturer is obliged to apply for an amended medical device license with regard to the modified device. The …

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