Harima Plant Expands ISO13485:2016 Certification Scope for Medical Device Quality Management System to "Design, Development and Manufacturing"

Daicel Corporation (Head Office: Minato-ku, Tokyo; President: Yasuhiro Sakaki) has expanded the scope of its Harima Plant's ISO13485:2016 medical device quality management system certification from the conventional "design and development" to "design, development and manufacturing," in order to accelerate the expansion of its medical device business into overseas markets. This expansion allows the Harima Plant to conduct all processes from the design and development to the manufacturing of medical devices under a quality management system based on the international standard ISO13485:2016. Currently, the Harima Plant is engaged in the design, development, and manufacturing of gas-powered needle-free drug and vaccine injectors. ISO13485 is an international standard for quality management systems for medical devices, established with the aim of ensuring the safety and maintaining the quality of medical devices. Regulatory schemes in the majority of countries require medical device manufacturers to establish a quality management system, and third-party certification of ISO13485 is indispensable for the international expansion of medical devices. The Daicel Group will continue to establish and expand its medical device business in the life science domain, contributing to the improvement of people's health and QOL. * Management Standard: ISO13485:2016 * Certification Registration Number: MD 759371 * Registration Date: April 14, 2026 * Scope of Registration: Design, development and manufacturing of gas-powered needle-free drug and vaccine injectors * Registered Organization Name: Daicel Corporation Harima Plant (805 Baba, Ibocho, Tatsuno City, Hyogo Prefecture) * Certification Body: BSI Assurance UK Limited * Harima Plant Obtains Medical Device Quality Management System ISO13485:2016 Certification at Innovation Park (Announced May 13, 2022) https://www.daicel.com/news/assets/pdf/20220513.pdf * Daicel Medical Co., Ltd. Obtains Class II Medical Device Manufacturing and Sales License (Announced May 13, 2024) https://www.daicel.com/news/2024/20240513_971.html * Notification of "Medical Device Manufacturing Business" Registration ~ Daicel Harima Plant completes registration as a medical device manufacturing facility ~ (Announced November 13, 2024) https://www.daicel.com/news/2024/20241113_1035.html * Daicel Medical Co., Ltd. Obtains Approval for Manufacturing and Sales of Gas-Powered Needle-Free Drug and Vaccine Injectors (Announced November 5, 2025) https://www.daicel.com/news/2025/20251105_1182.html