Canada · Health Canada · Medical devices
Review target
15 days
performance goal
Legal time limit
-
Not published
Steps
3
9 requirements
Application fee
CA$643
From April 1, 2026
Class II devices need a medical device licence. The application rests on an attestation that the maker holds objective evidence of safety and effectiveness, plus a quality system certificate. The review target is 15 days. Moderate-low risk devices, IVDs and software classified as Class II.
The official review target is 15 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The class ii medical device licence application is CA$643 for From April 1, 2026.
1. File the licence application; 2. Review (15 days); 3. Licence issued or refused.
Outcome: Medical device licence.
Legal basis: Medical Devices Regulations (SOR/98-282), sections 26, 32(2) and 36
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 15 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal. Official target in calendar days for the agency's work. It is not an actual review time. Time the applicant takes to answer questions is not counted. | 15 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Class II medical device licence applicationApplication · From April 1, 2026 · Small businesses can get 50% off. A small business filing its first medical device licence application can get the full fee waived. | CA$643 |
Other routes in Canada: Drug and device combination products, Class I medical devices (no device licence), Medical device licence, Class III, Medical device licence, Class IV, Special Access Program (medical devices). 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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.