Forms & Application Links
Submission portal
| Portal | Purpose | Link |
|---|---|---|
| HRES — Health Canada e-Submission portal | Submit Device Licence applications, MDEL applications, PSM requests, ITAs | hres.health-canada.gc.ca |
Databases
| Database | Purpose | Link |
|---|---|---|
| MDALL — Medical Devices Active Licence Listing | Search current Device Licences | health-products.canada.ca/mdall-limh |
| MDEL Listing | Search active establishment licences | health-products.canada.ca |
| Recalls and Safety Alerts | Search current and historical recalls | healthycanadians.gc.ca/recall-alert-rappel-avis |
| MedEffect Canada | Submit mandatory problem reports and voluntary reports | canada.ca/medeffect |
Guidance and policies
| Resource | Link |
|---|---|
| All guidance documents for medical devices | canada.ca — Guidance Documents |
| Fees for medical device submissions | canada.ca — Fees |
| Mandatory Standards list | canada.ca — Mandatory Standards |
| Recognised Standards list | canada.ca — Recognised Standards |
Legislation
| Resource | Link |
|---|---|
| Food and Drugs Act | laws-lois.justice.gc.ca/F-27 |
| Medical Devices Regulations (SOR/98-282) | laws-lois.justice.gc.ca/SOR-98-282 |
| Radiation Emitting Devices Act | laws-lois.justice.gc.ca/R-1 |
| Canada Gazette | canadagazette.gc.ca |
Contacting Health Canada
| Purpose | Contact |
|---|---|
| Medical Devices Directorate — general enquiries | Via HRES portal |
| Pre-Submission Meeting requests | Via HRES portal |
| Mandatory problem reports | MedEffect Canada |
| Recall notifications | Medical Devices Directorate via HRES |