THE KOREAN GOVERNMENT AIMS TO BE THE TOP 7 COUNTRIES IN THE MEDICAL DEVICE SECTOR BY 2020
With influential multi-national companies leading the tech sector in South Korea, there is also a thriving medtech industry in country and an established regulatory body, Ministry of Food and Drug Safety (MFDS) that oversees medical device approvals through its Medical Device Review Bureau. Like other regulatory systems, the MFDS requires approval of higher risk devices and classifies them by risk levels III and IV. In case of Class I and II, the Medical Device Information & Technology Assistance Center (MDITAC) requires authentication/notification of low risk level instead of MFDS. Like Brazil, only local companies can apply for a license so importers must authorize a local company to submit documentation for license on their behalf.
According to Export.gov, the total market size is about $5.7 Billion US Dollars. South Korea imports about $3.3 Billion USD medical devices with the United States being the largest import market and exports about $2.6 Billion USD.