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).

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Last Updated April 17, 2026, 21:55 (UTC)
Created April 17, 2026, 21:55 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2022-09-28 00:00:00
open_canada_keywords {"fr": ["processus d'inspection", "dispositifs médicaux", "inspecte les établissements de dispositifs médicaux", "vue d'ensemble", "évaluer la conformité", "Loi sur les aliments et drogues", "Règlement sur les dispositifs médicaux"], "en": ["inspection process", "medical devices", "inspects medical device establishments", "overview", "assess compliance", "Food-and-Drugs Act", "Medical-Devices Regulations"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Comment Santé Canada inspecte les établissements d'instruments médicaux : Aperçu
update_frequency as_needed