Description

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.

Resources

Name	Format	Description	Link
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

Tags

Topics

Categories