By Ames Gross South Korea is among the world’s leading economies with a gross domestic prod

By Ames Gross

South Korea is among the world’s leading economies with a gross domestic product that ranked 15th in the world in 2011, according to the International Monetary Fund. Benefiting from a growing economy and population of more than 48 million people, the healthcare market in Korea is expected to continue to expand. A recent report by the Korea Drug Research Association showed that the Korean medical device market is worth more than $3 billion with an expected annual growth rate of 10 to 15 percent during the next five years.

In order to better regulate the growing medical device market, the Korean Food and Drug Administration (KFDA) made significant changes in 2011 to the original Medical Device Act.

Regulatory changes of the revised act were fully enforced in April this year. Major changes include restructuring the pre-market approval process for medical devices; introducing a new Korea Good Manufacturing Practice (KGMP) Certification system for foreign manufacturers; regulating in-vitro diagnostics (IVD) products as medical devices; and accepting more foreign data in the medical device approval process.