Post-Market Overview
Obtaining a Device Licence or MDEL is the beginning of your regulatory obligations, not the end. Health Canada requires ongoing post-market activities throughout the commercial life of every medical device sold in Canada.
Key post-market obligations
| Obligation | Who | Where covered |
|---|---|---|
| Mandatory problem reporting | Manufacturers, importers, distributors | Mandatory Problem Reporting |
| Recalls & FSCAs | Manufacturers, importers, distributors | Recalls & Field Safety |
| Post-market surveillance | Manufacturers | Post-Market Surveillance |
| Device Licence amendments | Manufacturers | Amending a Device Licence |
| Distribution records | Importers, distributors | Distribution Records |
| Labelling compliance | Manufacturers | Labelling Requirements |
| MDEL maintenance | Importers, distributors | Establishment Licence |
| Annual fees | All licence holders | Annual Charges |
| Cooperation with inspections | All regulated parties | Inspection Program |
Post-market surveillance framework
Health Canada's post-market framework is based on monitoring, reporting, and responding:
- Monitor — collect post-market data through complaint handling, literature surveillance, and vigilance monitoring
- Report — report qualifying incidents to Health Canada within required timeframes (see MPR obligations)
- Respond — take corrective action (recalls, FSCAs, Device Licence amendments) when problems are identified
Consequences of non-compliance
Failure to meet post-market obligations can result in:
- Compliance letters from Health Canada
- Public warning letters
- Section 21 orders to stop sale
- Device seizure
- Criminal prosecution under the Food and Drugs Act
- Device Licence or MDEL suspension or cancellation
Legislative source: Medical Devices Regulations, SOR/98-282, ss 58–65 (post-market)