Free AI tool · No signupFree Nicaragua medical device classification tool
Describe your device and get a preliminary ANRS 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 Nicaragua classifier checks
The classifier compares your product description with current ANRS 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 Nicaragua?
- ANRS uses a risk-based framework. Possible classes include Medical devices: Class I, Class II, Class III, Class IV; IVDs: Class I, Class II, Class III. NTON Annex B contains the local numbered classification rules and four medical-device risk levels. ANRS classifies regardless of a foreign classification. IVD-specific rules 20, 22, 24 and 25 name I, II and III. No four-tier A-D or general-device class IV mapping is imposed on IVDs. The IVD-specific rules explicitly assign classes I, II and III according to the listed intended uses and risk conditions. The three class positions are normalized for comparison only. The device I-IV axis is not substituted for these local IVD rules. 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 Nicaragua classifier use?
- Current official ANRS classification requirements. Your result includes an explanation and links to the official sources used.
- Is the result an official ANRS 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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