Daicel Corporation
Daicel Medical Co., Ltd. receives Type 2 medical device manufacturing and sales license.
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Our group company Daicel Medical Co., Ltd. (Headquarters: Minato-ku, Tokyo, President and CEO: Nobuaki Ito) has received permission from the Tokyo Metropolitan Government as a Type 2 Medical Device Manufacturing and Sales Business as of April 22nd.
A medical device manufacturing and sales business is a business license required for a business that is ultimately responsible for medical device products distributed in the Japanese market.
By obtaining a Type 2 Medical Device Manufacturing and Sales Business License, we will be able to manufacture and sell medical devices that fall under Class II (Controlled Medical Devices) of the medical device classification*.
Going forward, we will continue to accelerate the expansion of Daicel Group’s overall life science field and medical device business to meet customer needs, and strive to further improve quality control. -Details of “Medical device manufacturing and sales industry”- Type of license: Type 2 medical device manufacturing and sales business Permit number: 13B2X10592
Name of office with main functions: Daicel Medical Co., Ltd. Location of office with main functions: JR Shinagawa East Building, 2-18-1 Konan, Minato-ku, Tokyo
*Medical devices are classified into four levels depending on the risk to the human body in the event of a malfunction. Class II medical devices (controlled medical devices) are the second class of medical devices from the lowest risk category, and are considered to pose a relatively low risk to the human body even if a malfunction occurs. Please refer to the link below for details on medical device classification. Pharmaceuticals and Medical Devices Agency Reviews, etc. Medical devices:
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0028.html More details about this release:
https://prtimes.jp/main/html/rd/p/000000163.000035577.html