Free AI tool · No signupFree Israel medical device classification tool
Describe your device and get a preliminary Ministry of Health Medical Device Division (AMAR) 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 Israel classifier checks
The classifier compares your product description with current Ministry of Health Medical Device Division (AMAR) requirements and looks for similar products already registered in Israel. 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 Israel?
- Ministry of Health Medical Device Division (AMAR) uses a risk-based framework. Possible classes include Class I, Class IIa, Class IIb, Class III. Israel has no domestic classification rulebook: devices are keyed to the classification of their reference market. Europe distinguishes four classes and the US FDA three, and where the two conflict the FDA classification prevails (AMAR Q&A). Track eligibility and dossier depth follow these classes in AMAR procedures REG-2023/04, REG-2024/03 and REG-2024/06. 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 Israel classifier use?
- Current Ministry of Health Medical Device Division (AMAR) requirements and similar registered products for context. Your result includes an explanation and links to the official sources used.
- Is the result an official Ministry of Health Medical Device Division (AMAR) 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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