ABSTRACT
Korea is the eleventh largest medical device market in the world and the third largest in Asia following Japan and China. In 2014, the market was estimated at about US$4.9 billion. In 2014, Korea spent around US$3 billion on the import of devices, which accounted 62% of the domestic market for the year. Korea imports the majority of high-tech devices from advanced countries, such as, the United States, Europe, and Japan. The domestic production of medical device was valued at US$4.6 billion in 2014, summing up to 11.6% of compound annual growth rate (CAGR) for 2010-2014. Korea has made a substantial growth in the export of medical devices in recent years. In 2014, the total amount of exports amounted to US$2.7 billion, leading to 27% of CAGR for the past five-year period from 2010. All Korean and foreign device manufacturers are required to have certification in compliance with quality management system standards or Korean Good Manufacturing Practice (KGMP) standards.
