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.