6. Conclusion. Based upon the medical industry paradigm shift driven by higher quality of life and aged society, Korea’s medical device market size is estimated at USD 3,886million with the CAGR 9.4% growth rate from 2004 to 2011. Because of its low technology level and immature industrial structure, the market’s dependency on imported products is relatively high at 65%. Therefore, Korea is one of the attractive markets for foreign medical device manufacturers. However, considering the recent regulation amendment by KFDA regarding medical device management to level it up to those of advanced countries, as well as the complex import procedure, it is not the easiest market to enter into. st
Among top 10 exporting countries to Korea, the US ranks 1 sharing 44.39% of total Korea’s medical device import, followed by Germany (13.63%). It is noticeable that the US is sharing more than 3 times exporting th value than the those of Germany. Switzerland ranks 5 , however, its share is relatively small with 4.57%. In order for Swiss companies to enter into Korea in short period of time and expand their market share, one rd must be well prepared for Korea’s new regulations such as adoption of IEC60601-1 3 , and the revision of GMP inspection for overseas manufacturer. Also strategic alliance with local medical device manufacturers will provide higher efficiency in entering into Korean market. Furthermore, one must consider items that are most potential in Korean market. Such prospective items include: u-healthcare products, disposable surgical apparatus, CT, MRI, and minimal invasive operation related goods.
Medtech Industry in Korea |
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