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: Medical devices are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA), under the Ministry of Health, Labour and Welfare (MHLW).
Devices are classified according to risk into Classes I, II, III and IV.
The registration process ranges from 8-16 months, depending on classification.
Licenses issued in Japan expire after five years.
An authorized representative is required.
An application of Foreign Manufacturers Accreditation (FMA) is required in addition to the product license.
Last updated on February 9 2015.
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