Free AI tool · No signupFree Rwanda medical device classification tool
Describe your device and get a preliminary Rwanda FDA 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 Rwanda classifier checks
The classifier compares your product description with current Rwanda FDA requirements and looks for similar products already registered in Rwanda. 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 Rwanda?
- Rwanda FDA uses a risk-based framework. Possible classes include Class A, Class B, Class C, Class D. Rwanda's own four-class device axis, from Class A (lowest risk) to Class D (highest risk), with the higher class prevailing where a device could fall into more than one, and a separate submission required for each device in a combination. 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 Rwanda classifier use?
- Current Rwanda FDA 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 Rwanda FDA 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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