New labelling and MDEL requirements for medical devices authorized under interim orders on September 1, 2021

New labelling and MDEL requirements for medical devices authorized under interim orders on September 1, 2021 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. 2023-02-27 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetymedical devicesMDELnew labelling requirementsLabelsofIOauthorized devicesIONo2 New labelling and MDEL requirements for medical devices authorized under interim orders on September 1, 2021HTML 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, 2021HTML 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

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.

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