Description

Labels of IO-authorized devices must be, at a minimum, in either English or French. There are also several additional requirements (for example, bilingual labelling) depending on whether the device is to be sold to the general public.

Resources

Name	Format	Description	Link
New labelling and MDEL requirements for medical devices authorized under interim orders on September 1, 2021	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/requirements-medical-devices-interim-order-september-2021.html
New labelling and MDEL requirements for medical devices authorized under interim orders on September 1, 2021	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/licences-etablissement/bulletin-conformite-materiels-medicaux/exigences-instruments-arrete-urgence-vigueur-septembre-2021.html

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