Free AI tool · No signupFree Macau medical device classification tool
Describe your device and get a preliminary ISAF 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 Macau classifier checks
The classifier compares your product description with current ISAF requirements and looks for similar products already registered in Macau. 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 Macau?
- ISAF uses a risk-based framework. Possible classes include Class I, Class IIa, Class IIb, Class III. 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 Macau classifier use?
- Current ISAF requirements and similar registered products for context. Your result includes an explanation and links to the official sources used.
- Is the result an official ISAF 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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