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 registration as a Medical Device Manufacturer from the Governor of Tokyo on August 27, 2026.

Medical Device Manufacturing Registration is a mandatory registration under Japan’s Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act) . It applies to facilities involved in medical device production processes, including device design and the storage of finished products within Japan.

With this registration, combined with the First-Class Marketing License that the company has already obtained, MediScan has established an integrated in-house structure encompassing the entire process— from medical device design and manufacturing to marketing and distribution.

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 registration marks a significant milestone toward the commercialization and market launch of our internally developed medical devices.

Registration Details
・Registration Category: Medical Device Manufacturing Registration
・Registration Number: 13BZ202033
・Validity Period: August 27, 2026 – August 26, 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