Korean MFDS guidelines ECG HF stimulation was recently published (June 12, 2015) in order to help completion of medical device license and technical documentation. The products covered are high frequency stimulation and electrocardiograph.
The guidelines describe a variety of high-frequency stimulation of different properties/techniques as well as electrocardiographs. The structure of the guideline is such that a lot of examples can be found with detailed requirements for documentation.
The links can be found below (in Korean):
– high-frequency stimulation
– electrocardiographs
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.
