Description

This document provides guidance on regulatory requirements in relation to medical device establishment licence (MDEL), such as when and how to apply for an MDEL, as well as how to maintain it once it is issued.

Resources

Name	Format	Description	Link
Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary	HTML		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
Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/licences-etablissement/directives-documents-orientation-politiques/orientation-concernant-octroi-licence-etablissement-instruments-medicaux-0016.html

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