Seoul, South Korea – On October 10, Shanghai MicroPort Medical (Group) Co ("MicroPort®") announced that its in-house developed Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") obtained the Korea Good Manufacturing Practice ("KGMP") from the Ministry of Food and Drug Safety ("MFDS") of South Korea.
According to statistics, South Korea ranks No.3 in Asia in the size of its medical device market, following Japan and China. In spite of the huge market, it is not easy for foreign companies to register medical devices in the South Korea market since they have to comply with strict quality system regulations required by the South Korean government. In November 2014, MicroPort® received the on-site inspection by the MFDS for its JIVE balloon product before its market launch in South Korea, and successfully passed the auditing to obtain the KGMP certification in December 2014.
As Firehawk® was granted the KGMP certification, it once again proved that MicroPort® quality system complies with the KGMP quality system regulations, and meanwhile it paves the way for Firehawk® to receive the regulatory approval in the South Korea market.