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(yī)療器械質(zhì)量體系（KGMP）認(rèn)證！ 

       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(rèn)真細(xì)致的工廠現(xiàn)場(chǎng)審核、專業(yè)嚴(yán)謹(jǐn)?shù)漠a(chǎn)品生命周期全文檔等審查環(huán)節(jié)，最終順利通過KGMP審核。這是中生北控憑借自身雄厚強(qiáng)大的研發(fā)實(shí)力，穩(wěn)定高效的生產(chǎn)能力，完善先進(jìn)的管理水平，繼ISO13485之后，取得的又一重量級(jí)的體系認(rèn)證。

       韓國是亞洲重要的醫(yī)療器械進(jìn)口國，醫(yī)療器械市場(chǎng)前景可觀。隨著韓國政府對(duì)進(jìn)口醫(yī)療器械產(chǎn)品的進(jìn)一步加強(qiáng)管理，2012年4月開始，韓國對(duì)進(jìn)口醫(yī)療器械產(chǎn)品提出更高要求，規(guī)定Ⅱ~Ⅳ類醫(yī)療器械生產(chǎn)廠家必須通過韓國MFDS的全面審核，取得KGMP認(rèn)證之后方可進(jìn)入韓國市場(chǎng)銷售。中生北控公司此次順利取得韓國KGMP認(rèn)證，吹響了中生北控產(chǎn)品進(jìn)軍韓國市場(chǎng)的號(hào)角，為中生北控拓展海外市場(chǎng)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.