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中生北控顺利获得韩国KGMP认证

        喜讯!中生北控公司顺利通过韩国食品药品安全部(MFDS)审查,取得韩国医疗器械质量体系(KGMP)认证! 

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       2018年6月底,韩国MFDS审核专家莅临中生北控开展了为期四天的全面审核工作。通过认真细致的工厂现场审核、专业严谨的产品生命周期全文档等审查环节,最终顺利通过KGMP审核。这是中生北控凭借自身雄厚强大的研发实力,稳定高效的生产能力,完善先进的管理水平,继ISO13485之后,取得的又一重量级的体系认证。

       韩国是亚洲重要的医疗器械进口国,医疗器械市场前景可观。随着韩国政府对进口医疗器械产品的进一步加强管理,2012年4月开始,韩国对进口医疗器械产品提出更高要求,规定Ⅱ~Ⅳ类医疗器械生产厂家必须通过韩国MFDS的全面审核,取得KGMP认证之后方可进入韩国市场销售。中生北控公司此次顺利取得韩国KGMP认证,吹响了中生北控产品进军韩国市场的号角,为中生北控拓展海外市场开辟了更广阔的空间!


 

    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.

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