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中生北控順利獲得韓國KGMP認證

        喜訊!中生北控公司順利通過韓國食品藥品安全部(MFDS)審查,取得韓國醫療器械質量體系(KGMP)認證! 

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       2018年6月底,韓國MFDS審核專家蒞臨中生北控開展了為期四天的全面審核工作。通過認真細致的工廠現場審核、專業嚴謹的產品生命周期全文檔等審查環節,最終順利通過KGMP審核。這是中生北控憑借自身雄厚強大的研發實力,穩定高效的生產能力,完善先進的管理水平,繼ISO13485之后,取得的又一重量級的體系認證。

       韓國是亞洲重要的醫療器械進口國,醫療器械市場前景可觀。隨著韓國政府對進口醫療器械產品的進一步加強管理,2012年4月開始,韓國對進口醫療器械產品提出更高要求,規定Ⅱ~Ⅳ類醫療器械生產廠家必須通過韓國MFDS的全面審核,取得KGMP認證之后方可進入韓國市場銷售。中生北控公司此次順利取得韓國KGMP認證,吹響了中生北控產品進軍韓國市場的號角,為中生北控拓展海外市場開辟了更廣闊的空間!


 

    Good news! After audit by Korea Ministry of Food and Drug Safer (MFDS), BioSino successfully get Korea Certificate of Good Manufacturing Practice (KGMP) for IVD reagent.

    At the end of June 2018, auditors from Korea MFDS related department came to BioSino, implemented a 4-day comprehensive, intensive and professional audit to BioSino factory and product full life-circle documents, and finally approved to issue KGMP to BioSino. After ISO13485, KGMP is another significant certificate which represents BioSino strong ability of R&D, manufacturing and management.

    Korea is an important import country of medical devices in Asia, which supplies a promising market for foreign export enterprises . However, since April 2012, foreign manufactures of Ⅱ~Ⅳcategory medical device are required to pass the comprehensive audit of Korea MFDS to get KGMP, before launching their products in Korea market. KGMP is the beginning for BioSino product to step into Korea market, as well as a great opportunity for BioSino to exploit oversea market.