Free AI tool · No signupFree Taiwan medical device classification tool
Describe your device and get a preliminary TFDA 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
Try an example
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 Taiwan classifier checks
The classifier compares your product description with current TFDA requirements and looks for similar products already registered in Taiwan. 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 Taiwan?
- TFDA uses a risk-based framework. Possible classes include Class I, Class II, 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 Taiwan classifier use?
- Current TFDA 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 TFDA 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.
Keep researching this market
More Taiwan medical device resources
Continue with this market