Apr 5, 2013

South Korea’s Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration, has released new data showing that medical device approvals increased by nearly seven percent from 2011 to 2012.

The MFDS attributes the increase to growing demands for devices among an aging South Korean population.

The increase in approvals falls in line with overall trends in Korean healthcare spending, which grew by 47% between 2005 and 2010. South Korea is now the fourth largest healthcare market in the Asia-Pacific region, following Japan, China and Australia.

Furthermore, medical device approval rates in South Korea may increase further in 2013 due not only to demographic trends, but also regulators’ recent move to simplify Korea Good Manufacturing Practice (KGMP) inspection requirements particularly for foreign manufacturers.


  • Stewart Eisenhart