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.
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basic information
At Shinwa Industry, we have established a clean room with a class of 10,000 or lower to continuously provide our customers with plastic products used in medical devices that meet safe and reliable quality standards. Our clean room employs a triple filter structure to achieve high cleanliness. Additionally, Shinwa Industry has strengthened its system to provide plastic molded products for the medical industry more safely and reliably than ever before. In recent years, we have responded to the demand for DNase-free, RNase-free, and endotoxin-free products, and we also accommodate sterilization through radiation (gamma rays, electron beams) and EOG sterilization. We are engaged in the development, design, and manufacturing of high-precision medical devices for gene therapy and infertility treatment, and we have obtained various patents.
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We have obtained medical device manufacturing licenses, ISO 13485 certification, and medical device sales licenses, and we operate a safe and secure production facility with a Class 10,000 cleanroom. Our highly skilled plastic molding technicians provide various VA/VE proposals to turn our customers' ideas into reality, contributing to the medical industry in Japan and around the world. If you have any concerns regarding medical plastic molding, please feel free to consult with Shinwa Kogyo Co., Ltd. first.
Company information
We provide plastic medical devices of assured quality. - Medical Device Manufacturing and Sales License Number: 11B2X10048 - Medical Device Manufacturing Registration Number: 11BZ200082 - ISO 13485 certified company - Precision molding in a clean room with a class of 10,000 or lower Shinwa Kogyo Co., Ltd. has been honing its plastic molding and mold manufacturing technologies since its establishment in 1974. Throughout this process, we have actively developed services such as 3D-CAD compatibility, product design, flow analysis, and mold design, providing our customers with services that go beyond just contract processing. Additionally, through our dealings with clients in the medical industry, we have been involved in numerous medical products, including the establishment of an in-house clean room with a class of 10,000, obtaining ISO 13485 certification, and acquiring licenses for medical device manufacturing and sales, as well as custom molding machines. We will solve all your concerns regarding medical plastic products with VA/VE proposals based on flow analysis and mold design technology by certified plastic molding specialists from the design stage. Please feel free to consult with us.
