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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
- Class II Medical Device Licence Amendment Application Form (PDF fillable/saveable (512 K)) [2022-08-10] (Doc Version - 140 K) Class IV Medical Device …
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
- 2 | Class II medical device licence amendment application form Protected B when completed For medical devices 2022/08/10directorate use device licence application …
Guidance on how to complete the application for a …
- 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.html
- Class II, III and IV medical devices must be licenced before they may be imported or sold in Canada. A licence is issued to the device manufacturer for each …
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
- I, the private label manufacturer, also hereby declare that the medical device named above is a private label medical device, as defined in the Guidance for Industry …
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 device application and report forms Medical Devices Licence Amendment Minor Change Form - Guidance for Changes to the Manufacturer's Name …
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 form is to facilitate the approval of device licence amendments where the change involved consists of the addition or deletion of new …
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
- Class III Medical Device Licence Amendment Application Form - Canada.ca Class III Medical Device Licence Amendment Application Form April 2014 This HTML …
Fees for the Examination of an Application for a Medical …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html
- Apr 1, 2022
Guidance on how to complete the application for a …
- https://publications.gc.ca/collections/collection_2021/sc-hc/H164-315-2021-eng.pdf
- licence will be issued to the manufacturer. A third party may submit a medical device licence application. The mailing address and name of this authorized regulatory …
Health Canada Notice on Interpretation of …
- https://www.regdesk.co/health-canada-notice-on-interpretation-of-significant-changes/
- The authority mentions that, in certain cases, an application for a new medical device license could be required instead of an application for an amended …
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