cybersecurity
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).
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