Certification

Can be certified with advanced technology in classⅡmedical device manufacturing and various product development

In today's society, there is a strong demand to ensure the quality, efficacy, and safety of medical devices, so much so that the name of the law was changed from the Pharmaceutical affairs law to the Pharmaceutical machine law in 2014 amid repeated revisions to the law.
We have established a quality management system based on the law, and we ensure the safety of product quality by thoroughly managing products and safety after shipping.

Medical device certification

Our Second factory can apply for the manufacture and sale of medical devices, because of we have acquired a class II medical device manufacturing industry and a second-class medical device manufacturing and sales business.
We can apply for certification and supply products after certification, even if the customer has only obtained a sales license or is unable to obtain certification on their own.
If considering mass production of medical devices, please feel free to contact us.

PSE conformity inspection

We provide support for conformity inspections of our own original products and imported products, as well as for conformity inspections of specified electrical appliances, or act as an agent for such products.
Certification under the Electrical appliance and Material safety law means "certification of conformity to standards by a third-party organization = passing a conformity inspection" and is not a proof of safety. Not only agency and support services, in addition to the above support services, our VA proposals related to product safety have been well received by manufacturers and importers.