Canada · Health Canada · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
6 requirements
Application fee
CA$5,519
From April 1, 2026
Class I devices, the lowest risk, do not need a device licence. Companies that import or sell them need a medical device establishment licence, and the safety and effectiveness rules still apply to manufacturers. Low-risk devices and IVDs that fall in Class I under the classification rules.
The medical device establishment licence (new or annual review) is CA$5,519 for From April 1, 2026.
1. Classify the device; 2. Apply for an establishment licence; 3. Establishment licence decision (120 days); 4. Annual licence review.
Outcome: The device can be sold through licensed establishments without a device licence.
Legal basis: Medical Devices Regulations (SOR/98-282), sections 9, 26 and 44
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 120 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
| Decisionperformance goal. Establishment licence decision target in calendar days. 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. | 120 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Medical device establishment licence (new or annual review)Establishment · From April 1, 2026 · Small businesses can get 25% off. | CA$5,519 |
Other routes in Canada: Drug and device combination products, Medical device licence, Class II, 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 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.