Guidance on Medical Device Establishment Licensing (GUI-0016)

Guidance on Medical Device Establishment Licensing (GUI-0016) This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL), including when and how to apply for an MDEL, and how to maintain an MDEL once issued. 2023-02-27 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGUI-0016regulatory requirementsmedical-deviceestablishment licenceMDEL Guidance on Medical Device Establishment Licensing (GUI-0016)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/document.html Guidance on Medical Device Establishment Licensing (GUI-0016)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/document.html

This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL), including when and how to apply for an MDEL, and how to maintain an MDEL once issued.

Data and Resources

Similar records