Korea FDA Medical Device

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.