Guidance Documents — By Topic
Health Canada publishes guidance documents that interpret and clarify the requirements of the Medical Devices Regulations. Guidance is not legally binding, but following it is the most reliable path to compliance.
All official guidance is available on the Health Canada guidance documents page.
Classification and regulatory pathway
| Document | Topic |
|---|---|
| Guidance on the Risk-Based Classification System for Non-IVD Medical Devices | How to apply the 16 Schedule 2 classification rules |
| Guidance on the Regulatory Framework for IVD Devices | IVD classification and regulatory pathway |
| Software as a Medical Device (SaMD) — Overview and Classification | IMDRF-aligned SaMD guidance |
| Guidance on Borderline Products | Distinguishing devices from drugs, NHPs, and cosmetics |
| Guidance on Combination Products | Determining the primary mode of action |
Device Licence applications
| Document | Topic |
|---|---|
| Guidance on Device Licence Applications for Class II Devices | Class II submission requirements |
| Guidance on Device Licence Applications for Class III and IV Devices | Class III/IV submission requirements |
| Guidance on Clinical Evidence Requirements | What clinical evidence is required by class |
| Guidance on Safety and Effectiveness Requirements (Schedule 1) | How to address Schedule 1 requirements |
| Guidance on Mandatory Standards | List of mandatory standards and how to attest compliance |
| Guidance on Pre-Submission Meetings | How to request and prepare for a PSM |
Quality management and MDSAP
| Document | Topic |
|---|---|
| Guidance on Quality Management Systems for Medical Devices | ISO 13485 and MDSAP requirements for Device Licence applications |
| Guidance on the Medical Device Single Audit Program (MDSAP) | MDSAP audit structure and accepted certificates |
Post-market
| Document | Topic |
|---|---|
| Guidance on Mandatory Problem Reporting | What to report, when, and how |
| Guidance on Medical Device Recalls | Recall process, classification, effectiveness checks |
| Guidance on Labelling of Medical Devices | Mandatory labelling content requirements |
| Guidance on Advertising Medical Devices | Permitted and prohibited claims |
Special device types
| Document | Topic |
|---|---|
| Guidance on IVD Devices — Analytical and Clinical Performance | Performance requirements for IVDs |
| Guidance on SaMD — Cybersecurity | Cybersecurity requirements for connected devices |
| Guidance on Reprocessing Single-Use Devices | Requirements for SUD reprocessors |
| Guidance on Custom-Made Devices | Custom-made device exemption criteria |
Official source