In a very similar way as US FDA addressed this topic, South Korean MFDS has announced measures to distinguish mobile medical devices from more fitness related application or devices.
The original public consultation is posted here.
Comments from the public can be submitted until April 7, 2014.
For instance, heart rate monitors and pulse rate monitors intended for leisure and fitness will be excluded from MFDS classification requirements.
If you wish to sell in South Korea you can contact us for a preliminary discussion. See also our services for the registration of medical devices in South Korea.
