On April 1st, 2018, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has raised the registration fees for most medical devices . PMDA fee increase is ranging from 8% to 15% across nine device categories as shown below:

• Class II and III new devices
• Class II and III improved devices with clinical data
• Class II and III generic devices with approval standards
• Class IV improved devices with clinical data
• Class IV improved devices without clinical data or approval standards
• Class IV generic devices without clinical data or approval standards
• Class IV generic devices with approval standard.