Free AI tool · No signupFree Uruguay medical device classification tool
Describe your device and get a preliminary MSP 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 Uruguay classifier checks
The classifier compares your product description with current MSP requirements and looks for similar products already registered in Uruguay. 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 Uruguay?
- MSP uses a risk-based framework. Possible classes include Clase I, Clase II, Clase III, Clase IV. Uruguay applies the MERCOSUR Reglamento Técnico de Registro de Productos Médicos (Res. GMC N° 25/21), internalised by Decreto N° 428/022, which derogated Decreto N° 7/001 (Res. GMC 40/00). 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 Uruguay classifier use?
- Current MSP requirements and similar registered products for context. Your result includes an explanation and links to the official sources used.
- Is the result an official MSP 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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