Prior to exporting medical device products to other countries, we comply with national regulations and obtain local certifications where the products are to be sold. At present, BenQ Materials has obtained certifications from Taiwan’s TFDA, the EU CE, U.S.FDA, and China’s CFDA, in addition to product certificates from numerous countries listed in the accompanying table.
Compliance with the EN ISO 14971:2012 Medical Device Risk Management Standard and ISO 14155:2011 Medical Device Clinical Evaluation Guideline is also needed during product clinical trials. Furthermore, the risk management of product development and the design,progress, recording and reporting processes of clinical trials must comply with standards and regulations, thereby ensuring thatthe clinical trials are implemented according to scientific methods, and reliable results can be obtained. For our sterile packagingmaterials product series, it is necessary to qualify further with the ISO 10993:2018 Medical Device Biocompatibility Test beforeshipping.