Free AI tool · No signupFree Canada medical device classification tool
Describe your device and get a preliminary Health Canada risk class, a clear explanation, official source links, and similar registered products where available.
Free · no loginStructured outputOfficial source linksRegistry evidence where available
Describe your device
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Tell us what the device does, who uses it, how it contacts the body, and whether it is powered, implantable, sterile, measuring, software, or an IVD.
Preliminary informational result — not an official regulatory decision.0 / 5,000
About this classifier
What the Canada classifier checks
The classifier compares your product description with current Health Canada requirements and looks for similar products already registered in Canada. It then gives you a suggested class, explains why it may apply, and shows the source links and product examples behind the result.
- How are medical devices classified in Canada?
- Health Canada uses a risk-based framework. Possible classes include Class I, Class II, Class III, Class IV. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.
- What information does the Canada classifier use?
- Current Health Canada requirements and class information from similar registered products. Your result includes an explanation and links to the official sources used.
- Is the result an official Health Canada classification decision?
- No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.
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