Health Canada Medical Device Licence Guidance

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 preparing the various device licence applications required when seeking an …

Guidance on Medical Device Establishment Licensing …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016.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

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

Guidance on Medical Device Establishment Licensing …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html

Manufacturers of a Class II, III or IV medical device must hold a medical device licence (MDL) to import or distribute their own medical device in Canada. Importers and distributors must hold an active MDEL …

Guidance for the Interpretation of Sections 28 to 31: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-interpretation-sections-28-31-licence-application-type.html

This new guidance document provides guidance to manufacturers in determining whether certain medical devices including components and parts can …

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

Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices. This Guidance Document has been updated …

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

This guidance document applies to Class II, III, and IV medical devices for which medical device licences have been issued by Health Canada. 2. Guidance This …

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 Draft Guidance Document: Terms and Conditions for Medical Devices February 1, 2023 By dicentra Health Canada is proposing expanding the Terms …

Health Canada Issues Final Guidance on Clinical …

https://www.emergobyul.com/news/health-canada-issues-final-guidance-clinical-evidence-requirements-medical-devices

The clinical evidence described in the document should be submitted for review as part of either: The medical device license application data requirements listed in subsections 32 (3) and (4) of the …