Canada · Health Canada · Combination products
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
Canada has no separate route for drug and device combination products. The agency decides whether the whole product follows the drug rules or the device rules, based on its principal mechanism of action. The product then uses that route. Products where a drug and a device are integrated into one product.
1. Classification request; 2. Bureau classification; 3. Classification committee (30 days); 4. Drug or device route.
Outcome: A classification. The product then follows a drug submission or a device licence route.
Legal basis: Health Canada Policy on Drug/Medical Device Combination Products (effective March 1, 2006)
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 30 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: New drug submission (new active substance), New drug submission or supplement (known substance), Abbreviated new drug submission (generic), DIN application with supporting data, Priority review, Notice of compliance with conditions, Extraordinary use new drug submission, Public health emergency drug (rolling review), Ministerial reliance order (foreign decision deeming), Access Consortium work sharing, Project Orbis (cancer drugs), Special Access Program (drugs), Class I medical devices (no device licence), . See all routes on the or explore them in the .
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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.