Description

This document is intended to help ensure consistency among Health Canada inspectors during medical device establishment inspections when classifying observations of deviations, deficiencies or failures according to risk, and assigning an overall compliance rating to an inspection.

Resources

Name	Format	Description	Link
Risk classification guide for medical device establishment inspections GUI-0079	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-risk-classification-medical-device-observations-0079/document.html#a1
Risk classification guide for medical device establishment inspections GUI-0079	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/information-produits-sante/instruments-medicaux/document-classification-risques-observations-instruments-medicaux-0079/document.html

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