Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary

Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary 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. 2023-02-27 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGUI-0016regulatory requirementsmedical-device establishment licenceMDEL Guidance on Medical Device Establishment Licensing (GUI-0016) - SummaryHTML 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) - SummaryHTML 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

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.

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