The Regulatory Affairs Organization is dedicated to contributing to the future of medical devices through a business specializing in medical device regulatory affairs consulting.

Medical device certification / approval is the gateway to selling medical devices in Japan and is a field that requires high knowledge and expertise in medical devices. While the device lag with overseas has become shorter than before, various medical devices have been developed that have never been seen before, and the demand for personnel familiar with the Pharmaceuticals and Medical Devices Law is increasing.

The Regulatory Affairs Agency will flexibly respond to the situation of the customer’s company, such as spot consulting on a time basis and outsourcing on a case-by-case basis.
We also train application staff for medical device approval / certification applications.

Through the seminars on the development of medical devices, QMS and approval / certification applications, we provide support to the company representatives of the Pharmaceuticals and Medical Devices Act.
Please feel free to contact us for confirmation, quotation and delivery date of each business.
We look forward to hearing from you.