Health Canada Medical Device Licence Renewal Form

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; …

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

Medical device licensing - Canada.ca

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/medical-device-licensing.html

Medical device licensing - Canada.ca Canada.ca Health Drug and health products Licensing, authorizing and manufacturing drug and health products Medical …

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

This guidance document provides medical device manufacturers and their regulatory correspondents with the steps involved in renewing a medical device …

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

Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) In light of COVID-19, please only email any completed MDEL application forms, …

Fees for Medical Devices - Canada.ca

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

The Medical Device Licence Application Fees apply only to Class II, III and IV medical device licence applications. The following types of medical devices are …

Licence, authorization and registration forms for drug …

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products.html

Medical device licensing Access forms and guidance documents to help you apply for a medical device licence. Also search for a licensed device using the listing database. …

Medical Devices Active Licence Listing (MDALL)

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html

Health Canada is the federal regulator of therapeutic products, including medical devices. We do not provide medical advice on the use of the products identified in this listing. The …

Health Canada Guidance on MDEL: …

https://www.regdesk.co/health-canada-guidance-on-mdel-annual-review-updating-cancellation-and-suspension/

How Can RegDesk Help? Submitting an Annual License Review Application According to the applicable legislation, any and all holders of the medical device establishment licenses …

What MDEL holders need to know about annual licence …

https://medtech.pharmaintelligence.informa.com/-/media/supporting-documents/medtech-insight/2022/01/d0122can_2.pdf

Medical device establishment licence (MDEL) application:Instructions (FRM-0292)Annual review documents (information)Guidance on medical device establishment licensing …