Japan Raises Medical Device Registration Fees
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.