Second-class medical device manufacturing and sales license, medical device manufacturing registration, and ISO 13485 certification.
Since its establishment, Shinwa Industry has prioritized quality and has been manufacturing various plastic molded products. In 2005, as part of this effort, we equipped ourselves with specialized custom machinery for the production of medical plastic products. By this time, our main customers had shifted to those in the pharmaceutical and medical industries. To accept commissions for plastic molding from customers with medical device manufacturing and sales licenses, we obtained a medical device manufacturing and sales license in 2007 (and a medical device manufacturing registration certificate in 2017).
Furthermore, as proof of our management system required for medical devices, we obtained ISO 13485 certification in September 2019. Among plastic molding manufacturers in Japan, few have acquired ISO 13485, and at Shinwa Industry, we achieved this certification as a testament to the trust and reliability we offer to our business partners.
In 2020, we obtained a second-class medical device manufacturing and sales license. As a result, plastic molding for the medical industry has become even more central to our operations, and we are now able to accommodate hygiene and sterilization processes.