INTER MD INC.
What should consider before launching a medical device in Korea?
The first thing would be to check “if a similar product has been in the Korea market” and “if the medical procedure wherein the medical device is used has been implemented in the Korea hospitals”. When substantial equivalency is not proven, a more thorough review must be processed including human clinical trial report on the product. The number of the subjects must be determined by a statistical calculation and the safety and efficacy must be substantiated by a statistical design.