Medical Devices Regulations (SOR/98-282) — Overview
What are the Medical Devices Regulations?
The Medical Devices Regulations (SOR/98-282), made under the Food and Drugs Act, are the principal regulations governing the pre-market and post-market requirements for medical devices in Canada. They came into force in 1998 and have been amended multiple times since.
Structure of the Regulations
The MDR is organized into Parts and Schedules:
Parts
| Part | Content |
|---|---|
| Part 1 — Interpretation | Definitions |
| Part 2 — General | General requirements applicable to all devices |
| Part 3 — Device Licences | Pre-market licensing for Class II–IV devices (ss 26–43) |
| Part 4 — Establishment Licences | MDEL requirements for importers, distributors, and Class I manufacturers (ss 44–57) |
| Part 5 — Distribution Records and Problem Reporting | Post-market record-keeping and mandatory problem reporting (ss 58–65) |
| Part 6 — Special Access to Devices | Special Access Program and Investigational Testing Authorization (ss 66–89) |
| Part 7 — Custom-Made Devices | Exemptions and requirements for custom-made devices (s 90) |
| Part 8 — Transitional Provisions and Consequential Amendments | Historical transition provisions |
Schedules
| Schedule | Content |
|---|---|
| Schedule 1 | Safety and Effectiveness Requirements |
| Schedule 2 | Classification Rules (16 rules for devices; separate IVD rules) |
| Schedule 3 | Fees (cross-reference to Fees Order) |
Key amendments
The Medical Devices Regulations have been amended several times since 1998, including:
- Amendments to classification rules for new device types
- Amendments to add MDSAP recognition
- Amendments to add mandatory problem reporting requirements
A full list of amendments is maintained at laws-lois.justice.gc.ca.