Nissha Obtains MDSAP Certification for Manufacturing Site at Global Headquarters in Kyoto

Nissha Co., Ltd. (hereinafter "Nissha") has obtained certification under the Medical Device Single Audit Program (MDSAP) for its manufacturing site at the Global Headquarters in Kyoto.

Nissha brings together diverse technologies and human capabilities to address global challenges in the medical, mobility, and sustainable materials, aiming to create both economic and social value. In the medical segment, we are actively expanding our business, with our Global Headquarters in Kyoto serving as a key manufacturing site for medical devices for the Japanese and North American markets.

MDSAP (Medical Device Single Audit Program) is an international audit program that integrates regulatory requirements from five participating countries-the United States, Canada, Brazil, Australia, and Japan-allowing medical device manufacturers to demonstrate compliance with multiple countries' quality management system standards through a single audit. This program streamlines audits, enhances global competitiveness, and reduces costs compared to separate country-specific inspections.

Our Global Headquarters has already established a robust quality management system, including ISO 13485:2016 certification. With the acquisition of MDSAP certification, we are now better positioned to serve the North American market and further strengthen our global OEM medical device manufacturing capabilities.

• Nissha Obtains ISO 13485 (Quality Management System for Medical Devices) Certification for Global Headquarters in Kyoto