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AG9亚游順利獲得韓國KGMP認證

        喜訊!AG9亚游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係(KGMP)認證! 

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       2018年6月底,韓國MFDS審核專家蒞臨AG9亚游開展了為期四天的全麵審核工作。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AG9亚游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之後,取得的又一重量級的體係認證。

       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的全麵審核,取得KGMP認證之後方可進入韓國市場銷售。AG9亚游公司此次順利取得韓國KGMP認證,吹響了AG9亚游產品進軍韓國市場的號角,為AG9亚游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), Biosesino 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 Biosesino, implemented a 4-day comprehensive, intensive and professional audit to Biosesino factory and product full life-circle documents, and finally approved to issue KGMP to Biosesino. After ISO13485, KGMP is another significant certificate which represents Biosesino 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 Biosesino product to step into Korea market, as well as a great opportunity for Biosesino to exploit oversea market.