Description

This guidance document clarifies the application of the risk classification rules for IVDDs set out in Part II of Schedule I of the Medical Devices Regulations, and was recently rewritten to include updated examples and to conform to Good Guidance Practices.

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Name	Format	Description	Link
Notice: Publication of the Guidance Document - Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-publication-guidance-document-guidance-risk-based-classification-system-vitro-diagnostic.html
Notice: Publication of the Guidance Document - Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/activites/annonces/avis-publication-ligne-directrice-orientation-systeme-classification-fonde-risque-instruments-diagnostiques.html

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