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Medical

實驗室實驗

Medical in Japan

In Japan, medical devices are categorized into four classes based on their risk levels:

​

-Class I (very low risk),

-Class II (low risk),

-Class III (moderate risk), and

-Class IV (high risk).

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​To legally market medical devices in Japan, foreign manufacturers must either obtain approval or certification, or submit a notification, depending on the device classification. 

 

This must be done in accordance with the PMD Act and through a Japanese Marketing Authorization Holder (MAH), a Japanese manufacturer designated by the foreign manufacturer, or a Designated Marketing Authorization Holder (DMAH).

手術室

1）Class I to IV medical device registration.

2）Medical products for human and animal use local representative service.

3）MAH and DMAH local representative service. 

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