Korea: Additional Requirements for Some High-Risk Medical Devices

South Korea’s Ministry of Food and Drug Safety (MFDS) has announced additional high risk medical device product types that must be tracked post-registration. Since late last year, importers of certain high-risk implantable devices have been required to report on the status of the devices each month. Initially, this reporting requirement applied to 28 types of implants such as artificial joints and blood vessels. Recently, the MFDS has expanded this list to 52 types of implantable medical devices.

The MFDS will also require clinical data for many high-risk medical device registrations starting in January of 2016. The list of devices potentially covered by this requirement includes implantable pacemakers, implantable defibrillators and iliac stents. Currently, sponsors of many of these devices do not need to submit clinical data if the device sponsor can show equivalence to a predicate device marketed in Korea.