Daicel Medical Ltd. (Head Office: Minato-ku, Tokyo; President: Noriaki Ito), a Daicel Group company, obtained a Second-class marketing license for medical devices from the Tokyo Metropolitan Government on April 22, 2024.

A "Marketing license for medical devices" is required for companies that assume ultimate responsibility for medical device products distributed in the Japanese market.

Obtaining a Second-class marketing license for medical devices enables the manufacturing-and-selling-business of medical devices classified as Class II (controlled medical devices) or lower according to the medical device classifications*.

Daicel will continue to accelerate the expansion of the Group's Life Science field in general and its medical device business in particular to meet the needs of its customers, while striving to further improve quality control.

Details of "marketing license for medical devices."
License classification: Second-class
License number: 13B2X10592
Name of the office with principal functions: Daicel Medical Ltd.
Location of principal office: JR Shinagawa East Building, 18-1, Konan 2-chome, Minato-ku, Tokyo

*Medical devices are classified into four levels according to the risk to the human body in the event of a malfunction. Class II medical devices (controlled medical devices) are the second-from-the-lowest class of medical devices according to risk assessment and are considered to be of relatively low risk to the human body in case of malfunction.

For details on the classification of medical devices, please refer to the following link.
Medical devices | Pharmaceuticals and Medical Devices Agency (pmda.go.jp)

For inquiries regarding this matter, please contact:
Daicel Medical Ltd.
JR Shinagawa East Building, 2-18-1 Konan, Minato-ku, Tokyo 108-8230, Japan
TEL : +81-3-6711-8156

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Daicel Corporation published this content on 15 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 May 2024 11:06:49 UTC.