Responsible Product
We ensure that the design, manufacturing, quality control, and shipping of our products meet customer expectations. All products comply with relevant safety and labeling regulations in various countries, such as medical devices. We strive for continuous innovation to collaborate with customers in developing innovative and sustainable technology products. Additionally, we aim to reduce the use of organic solvents and minimize waste generation.
All Business Units
Completed Product Development Procedure Manual
Healthcare Products
National Industrial Innovation Award - New Generation Silicone Hydrogel Material
Waterproof and breathable textiles
Taiwan Excellence Award Gold Award - Xpore Waterproof and Breathable Ocean Waste Recycled Yarn Functional Fabric
Product Safety and Marketing Labels
Before the sale of any medical devices sold by BenQ Materials in various countries, it is necessary to obtain the required national regulations and certifications of the respective sales regions. Currently obtained certifications include Taiwan TFDA, EU CE, US FDA, China CFDA, and others.
During clinical trials, products must also comply with EN ISO 14971:2012 medical device risk management standards and ISO 14155:2011 guidelines for clinical evaluation of medical devices. These standards ensure that risk management, design, conduct, recording, and reporting of clinical trials are in compliance to guarantee scientifically conducted and reliable results. Sterilization packaging series products must pass ISO 10993:2018 biocompatibility testing before shipment.
| Countries | Applicable Product Regulations |
|---|---|
Malaysia |
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Thailand |
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Indonesia |
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Vietnam |
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Philippines |
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Spain |
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