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Japan Medical Device
REGULATION

Classification

The Classification is from I to IV, based on the risk of medical devices. It is important to identify your medical device. If you want to know your product classification, please contact IM Japan.

NOTE: Stand-alone software is regarded as Medical Device. If your stand-alone software is equivalent to Class I, it is not regarded as Medical Device.

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This is the Classification for IVD.

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Authority and Timeline

The review  time depends on the classification. But taking authority consultation may help reduce review time. An appropriate communication is one of the successful strategies. The authority also depends on classification. Third party is specialized in reviewing class II device, there are more than 10 Third partis are available in Japan.

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