In April 2013, the Korean Food and Drug Administration (KFDA) reported that for the first time ever, approval rates for domestically manufactured medical devices surpassed those for imported medical devices.
In 2012, the total number of KFDA medical device approvals was 3,100. This was an increase of nearly 7 percent from 2011, when total device approvals numbered 2,900.
The increase reflects changes in the KFDA’s medical device approval process. The process was streamlined last year with the passage of the Medical Device Act. Under the new Act, lower risk devices have a shorter timeline for registration and fewer requirements. Reviews of Class II medical devices are now performed by third party organizations, and more foreign clinical trial data is accepted.
According to the KFDA, the increased pace of medical device approvals should continue through 2013. The KFDA says it wants to be responsive to Korea’s rapidly aging population, which is demanding more and better quality medical devices.