Official requirements
We check current classification information from ARCSA and government websites and show you the source links.
Free AI tool
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Free Ecuador medical device classification tool
Describe your device and get a preliminary ARCSA risk class, a clear explanation, official source links, and similar registered products where available.
Describe your device
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
How it works
What the Ecuador classifier checks
The classifier compares your product description with current ARCSA requirements and looks for similar products already registered in Ecuador. It then gives you a suggested class, explains why it may apply, and shows the source links and product examples behind the result.
Similar registered products
Where available, we show comparable products already registered in Ecuador so you can review the result in context.
A clear preliminary answer
You receive a suggested risk class, the reasons it may apply, and what should be confirmed before filing.
Frequently asked questions
Ecuador medical device classification FAQ
How are medical devices classified in Ecuador?
ARCSA uses a risk-based framework. Risk classes I through 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.
Is this Ecuador medical device classification tool free?
Yes. The preliminary ARCSA classifier is free to use and does not require an account. Fair-use limits help keep it available to everyone.
What information does the Ecuador classifier use?
Current ARCSA 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 ARCSA 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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