MediScan Co., Ltd. (Head Office: Chuo-ku, Tokyo; President & CEO: Koichiro Yoshino; hereinafter referred to as “MediScan”) is pleased to announce that the company obtained a First-Class Marketing License for Medical Devices from the Governor of Tokyo on April 13, 2026.

The First-Class Marketing License for Medical Devices is a mandatory license under Japan’s Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act). It allows the Marketing Authorization Holder to handle all classes of medical devices in manufacturing and sales, including the highest-risk Class IV medical devices, which may have a significant impact on human life and health.

MediScan is engaged in the research and development of non-invasive breast cancer screening technology by analyzing volatile organic compounds (VOCs) present in exhaled breath. Obtaining this license marks a significant milestone toward the future commercialization and market launch of our internally developed medical devices.

License Details
・License Category: First-Class Marketing License for Medical Devices
・License Number: 13B1X10475
・Validity Period: April 13, 2026 – April 12, 2031
・Issuing Authority: Governor of Tokyo

MediScan will continue to pursue its vision of developing “screening technologies that everyone can access with confidence.” By offering new diagnostic options that are non-invasive, highly accurate, and convenient, we aim to advance healthcare and create new possibilities in medical diagnostics.

Contact

MediScan Co., Ltd.
TEL: +81-3-6280-6895
E-mail: info@mediscan.co.jp