Free AI tool · No signupFree Ethiopia medical device classification tool
Describe your device and get a preliminary EFDA 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 Ethiopia classifier checks
The classifier compares your product description with current EFDA classification requirements. 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 Ethiopia?
- EFDA uses a risk-based framework. Possible classes include IVDs: Class A, Class B, Class C, Class D; Medical devices: Class I, Class II, Class III, Class IV. Ethiopia classifies IVD medical devices on a separate four-class axis keyed to individual and public-health risk, from Class A (low individual and low public-health risk) to Class D (high individual and high public-health risk). Ethiopia's own device class axis: four classes, Class I being the lowest risk. EFDA/GDL/046 Table 1 gives the general approach and EFDA/GDL/041 carries the classification rules and the same four-class axis. 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 Ethiopia classifier use?
- Current official EFDA classification requirements. Your result includes an explanation and links to the official sources used.
- Is the result an official EFDA 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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