Canada · Health Canada · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
3 requirements
Application fee
-
Health care professionals can ask for a custom-made or unlicensed device for patients with an exceptional need. Emergencies get priority, and the agency aims to reply to other requests within 3 working days. Emergency use, or when usual therapies have failed or are not available.
1. Professional files the request; 2. Decision (3 days).
Outcome: Authorization to import and sell the device to the professional.
Legal basis: Medical Devices Regulations (SOR/98-282), Part 2
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 3 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Canada: Drug and device combination products, Class I medical devices (no device licence), Medical device licence, Class II, Medical device licence, Class III, Medical device licence, Class IV. See all routes on the Canada page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.