At the Regulatory Affairs Organization,
medical device regulatory experts provide the services required
for each customer from application to insurance application
“Medical equipment” includes a variety of devices, instruments, and technologies, and a variety of devices are being developed around the world as science advances.
In order to bring such products to the market, it is necessary to respond to the type of equipment and the regulations of each country.
The Regulatory Affairs Organization provides regulatory affairs consulting for medical devices. Please select your desired service from the list below.
Regulatory Affairs Consultation
List of consulting services of the Regulatory Affairs Organization
PDMA face-to-face advisory support
Support for the preparation of materials for face-to-face advice implemented by the Medical Devices Agency（PMDA)
Consulting plan details
Three plans are available for consulting methods, periods and costs