Japan Raises Medical Device Registration Fees

April 17, 2018

Japan’s Pharmaceuticals and Medical Devices Agency raised its registration fees for most medical devices effective April 1.

The new fees for pre-market approval for Class II, III and IV devices represent an increase of about 8 percent to 15 percent.

The updated fees range from $147,012 for registering a new Class IV device, $107,998 for a Class II/III device to $86,114 for a reprocessed single-use Class IV device.

The PMDA also increased fees for devices changes, charging roughly half of the fee for a new PMA registration for devices in the same class.

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