Starting from April 1, 2018, Japan increased its registration fees for medical devices. Japan’s Pharmaceutical and Medical Device Agency (PMDA) announced fee increases of 8 to 15 percent for Class II, III, and IV devices. Under the new structure, a new Class IV device would cost $147,000 to register, while a Class II/III device would cost around $86,000.
The agency also raised the fee for device changes, which stands at about half the price of a new registration.