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HBI, medical device factory KGMP approved

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작성일 14-01-08 13:29


GeneMatrix's subsidiary HBI obtained the approval of the excellent medical device manufacturing and quality management standard (KGMP) from the Ministry of Food and Drug Safety on December 24 for a newly built factory dedicated to in vitro diagnostic medical devices in Korea Biopark in Pangyo Techno Valley. , It started full-scale operation.

Through the KGMP approval of this medical device factory, HBI is equipped with cutting-edge facilities and facilities suitable for the production of high-risk infectious agents immunological test reagents and medical device products in the molecular diagnosis category as well as immunochemical test reagents for in vitro diagnostics. In addition, as the next-generation genome diagnostic products such as B-type, hepatitis C, cervical cancer, and liver cancer, which are customized medical molecular diagnostic diagnostic products employing the original technology of Gene Matrix, are entrusted to production at the KGMP factory in Pangyo, both companies have quality homeostasis and product synergy. I can look forward to it.

By acquiring KGMP, we have been equipped with production quality management facilities that comply with international guidelines as well as domestic regulations in parallel with the existing ISO13485, ensuring quality excellence for expanding into the global market. HBI will actively target the domestic and overseas in vitro diagnostic medical device market.