Market Surveillance & Enforcement — Overview
Purpose
Health Canada conducts market surveillance to verify that medical devices on the Canadian market comply with the Food and Drugs Act and Medical Devices Regulations. Market surveillance activities identify non-compliant devices, take corrective actions, and protect Canadians from unsafe devices.
Key market surveillance activities
| Activity | Description |
|---|---|
| Compliance inspections | On-site inspections of manufacturers, importers, and distributors |
| Post-market sampling and testing | Purchasing and testing devices from the market against regulatory requirements |
| Complaint and incident analysis | Analysing mandatory problem reports and other safety signals |
| Recall monitoring | Overseeing recall execution and effectiveness |
| Border enforcement | Working with CBSA to identify and intercept non-compliant imports |
| Import alerts | Targeted surveillance of specific manufacturers or products of concern |
Who is subject to surveillance
All regulated parties are subject to Health Canada market surveillance:
- Manufacturers (Canadian)
- Importers (MDEL holders)
- Distributors (MDEL holders)
- Foreign manufacturers' Canadian representatives
Prioritisation
Health Canada prioritises surveillance activities based on risk, using:
- Mandatory problem reports and recall data
- Post-market monitoring signals
- Intelligence from international regulatory partners (FDA, TGA, EU authorities)
- Complaints from healthcare professionals, patients, and industry
High-risk devices (Class III and IV) and devices subject to safety signals receive priority surveillance attention.
Consequences of non-compliance
Health Canada has a range of enforcement tools — see Compliance & Enforcement.
Legislative source: Food and Drugs Act, RSC 1985, c F-27, ss 22–23 (inspection powers); Medical Devices Regulations, SOR/98-282