Daicel Corporation
Daicel Corporation (Head Office: Minato-ku, Tokyo; President & CEO: Yasuhiro Sakaki) has expanded the scope of ISO 13485:2016 medical device quality management system certification at its Harima Plant from "design and development" to "design, development, and manufacturing" in order to accelerate the expansion of its medical device business into overseas markets.
As a result, our Harima Plant can now carry out all processes from design and development to manufacturing of Daicel Injector P1 SC under ISO 13485:2016 quality management system.
ISO 13485 is a standard for quality management systems for medical devices, and is an international standard established to ensure the safety and quality of medical devices. Most countries' legal and regulatory schemes require medical device manufacturers to establish quality management systems, making ISO 13485 third-party certification essential for the international expansion of medical devices.
The Daicel Group will continue to accelerate the expansion of its life sciences field and medical device business, contributing to the improvement of people's health and quality life.
<Certification Overview>
Management Standard : ISO13485:2016
Certification Registration Number: MD 759371
Registration Date : April 14, 2026
Scope of Registration : Design, development, and manufacture of gas-powered needle-free injectors for pharmaceuticals and vaccines
Registered Organization Name : Daicel Corporation Harima Plant
(805 Baba, Ibogawa-cho, Tatsuno City, Hyogo Prefecture, Japan)
Certification Body : BSI Assurance UK Limited
<Related past releases>
Daicel Medical Ltd., a Daicel Group company, has obtained manufacturing and sales approval for a Gas-powered, Needle-free Injector for pharmaceuticals and vaccines. (November 5, 2025)
https://www.daicel.com/en/news/2025/20251105_1181/
Daicel Harima Plant completes registration as a medical device manufacturing plant.
( November 13, 2024)
https://www.daicel.com/news/2024/20241113_1035.html (This page is written in Japanese.)
Daicel Medical Ltd., a Daicel Group company, obtains a Second-class marketing license for medical devices. (May 15, 2024)
https://www.daicel.com/en/news/2024/20240515_972/
Daice Harima Plant obtains ISO 13485:2016 Quality Management System Certification for Medical Devices. (May 13, 2022)
https://www.daicel.com/en/news/assets/pdf/20220513_2.pdf
<Contact Information>
Daicel Corporation
Corporate Communication Division
TEL: +81-3-6711-8121