How Health Canada inspects medical device establishments: Overview

How Health Canada inspects medical device establishments: Overview These guidelines describe how Health Canada inspects licensed medical device establishments (companies). They describe the inspection process and explain how inspectors assess compliance with the Food and Drugs Act (the Act) and Medical Devices Regulations (the Regulations). 2023-02-27 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyinspection processmedical devicesinspects medical device establishmentsoverviewassess complianceFood-and-Drugs ActMedical-Devices Regulations How Health Canada inspects medical device establishments: OverviewHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/inspects-medical-device-establishments-0064.html How Health Canada inspects medical device establishments: OverviewHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/information-produits-sante/instruments-medicaux/inspecte-etablissements-instruments-medicaux-0064.html

These guidelines describe how Health Canada inspects licensed medical device establishments (companies). They describe the inspection process and explain how inspectors assess compliance with the Food and Drugs Act (the Act) and Medical Devices Regulations (the Regulations).

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