Official requirements
We check current classification information from PMDA / MHLW and government websites and show you the source links.
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Free Japan medical device classification tool
Describe your device and get a preliminary PMDA / MHLW 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 Japan classifier checks
The classifier compares your product description with current PMDA / MHLW requirements and looks for similar products already registered in Japan. 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 Japan 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
Japan medical device classification FAQ
How are medical devices classified in Japan?
PMDA / MHLW 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 Japan medical device classification tool free?
Yes. The preliminary PMDA / MHLW classifier is free to use and does not require an account. Fair-use limits help keep it available to everyone.
What information does the Japan classifier use?
Current PMDA / MHLW requirements and similar registered products for context. Your result includes an explanation and links to the official sources used.
Is the result an official PMDA / MHLW 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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