MFDS(Ministry of Food and Drug Safety), which is equivalent to US FDA, requires the submission of ‘Technical Documents’ for the certification and approval of medical devices.

In principle, Class I & II devices are certified by ‘Medical Device Information and Technology Assistance Center(MDITAC) the ‘National Institute of Medical Device Safety Information (NIDS) and Class III & IV devices are approved by MFDS.

However, Class I & II devices in categories below must be approved by MFDS.
 > which require clinical test reports
 > Digital Healthcare related (ex. telemedicine system)
 > Undefined Nomenclature & classification regulation
 > Combined with pharmaceuticals, etc.