Regulatory Affairs / ISO Certification

Regulatory Affairs / ISO Certification


We comply with the Japanese Pharmaceuticals and Medical Devices Act, acquire and maintain approvals, certifications, and notifications for manufacturing and marketing medical devices.
We have acquired business licenses and completed registrations listed below as stipulated by the Act, and have established an internal procedure for business operations in compliance with laws and regulations.

Internal procedures in compliance with laws and regulations
  • First-class marketing license for medical devices
  • Medical device manufacturer registration
  • Specially controlled medical devices sales/rental certificates
  • License for repairing medical devices

In addition, we have established a system to obtain a wide range of the latest legal and regulatory trends in a timely manner and reflect them in our business policies.
Our employees appropriately understand the legal and regulatory information necessary to bring innovative medical devices to market and promote their work. We are also preparing to partner with overseas companies to develop products manufactured and sold in Japan, to the overseas markets.


We, Riverfield, are ISO13485:2016 certified, an international standard for Quality Management System (QMS) for medical devices, and have established a system to carry out activities, such as design, development, manufacturing, and post-marketing safety management, for safe, useful, and high-quality products.

Notice of Acquisition of ISO13485 Certification (PDF)

Development of medical devices that have quality, efficacy, and safety

Since our first ISO13485:2016 certification in 2019, we have continued to practice QMS maintenance and improvement activities on a daily basis, reflecting the requirements of ISO13485:2016 in every detail of our QMS.
In addition, since ISO13485:2016 is at the core of medical device laws and regulations in many countries, obtaining this certification means that the foundation is in place for overseas expansion.

We have many employees with deep knowledge of medical device QMS. We are conducting educational activities on ISO13485:2016 not only internally but also externally to establish a framework that comprehensively ensures the sustainability of the quality, efficacy, and safety of our medical devices.

We ensure that all Riverfield’s employees have accurate knowledge of the medical device QMS to continue to offer medical devices with quality, efficacy, and safety.


Development of the latest medical equipment

With “Patient First” philosophy in mind, we deliver useful and safe state-of-the-art medical devices to patients and physicians.

Our mission is to revitalize the entire healthcare industry by promoting the use of state-of-the-art medical devices, thereby improving healthy life expectancy.