Health Canada Medical Device Licence Amendment Form

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Medical device application and report forms

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 for a New Medical Device Licence for a Private Label Medical Device; Declaration of Conformity; Bed-related Entrapment and Fall Report Form; Class III Medical Device Licence Amendment Application Form

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

Please indicate your consent by completing this form and sending it with your application for a new medical device licence, or any time after a licence has been granted. …

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 …

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

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

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 …

Licence Amendment Fax-Back Form - canada.ca

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

Licence Number to be Amended Application Number Licence Amendment Fax-Back Form For Changes to the Name of the Device Only Please submit to the Medical Devices …

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

Class II medical device licence amendment application form (disponible en français) Name of device licence being amended Licence number to be amended (provide the latest …

Medical Device Establishment Licence (MDEL) …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html

Health Canada's Compliance and Enforcement Policy for Health Products (POL-0001) and Guidance on Medical Device Compliance and Enforcement (GUI-0073) state that the …

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 …

Health Canada Draft Guidance Document: Terms and Conditions …

https://dicentra.com/blog/article/health-canada-draft-guidance-document-terms-and-conditions-for-medical-devices

Health Canada is proposing expanding the Terms and Conditions (T&Cs) on Class II to IV medical device licences to support the life cycle approach for regulating …

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