We are pleased to announce that, effective September 27, 2021, the Namicos Shiga Plant has been certified for ISO13485, the global quality standard for the medical device industry. This certification proves that Namicos has established and is operating a quality management system that satisfies the highest requirements of US, EU and Japanese regulatory agencies.
This ISO13485 qualification marks an important milestone in Namicos’ business development as we expand into new lines of medical device services that our clients desire. Namicos is also licensed by the Japanese Government as a Marketing Authorization Holder (MAH) for both Class I and Class II Medical Devices and engages in the registration, import and marketing of foreign-manufactured medical devices.
In addition to ISO13485, we maintain our ISO15378 certification. ISO15378 is an international standard of quality management system for companies involved in the manufacture and supply of primary packaging materials for pharmaceutical use, with reference to Good Manufacturing Practice (GMP).
With these qualifications, we remain committed to achieving the most stringent standards of excellence and quality in our manufacturing and services and delivering a high degree of assurance and peace of mind to our clients across the world.
About Namicos’ MAH and Medical Device Services
Namicos is a leading manufacturer and supplier of pharmaceutical packaging and solutions.
In cooperation with global medical device manufacturers, Namicos supports multinational pharmaceutical and life sciences companies by acting as an MAH on behalf of the manufacturer from whom they wish to procure medical devices. We also offer a variety of complimentary packaging solutions, including customized visual inspections, assembly of packaging components, and medical kitting, to help pharmaceutical companies meet Japanese quality standards and reduce labor costs.