Guidance by Device Type and Grade
MFDS publishes device-type-specific guidance covering:
- Active devices (electrically powered)
- Implantable devices (orthopaedic, cardiac, neurology)
- IVD devices (by analyte category)
- Software and SaMD
- Combination products
- Sterile devices
- Home-use / patient-use devices
Finding device-type guidance
Search the MFDS website guidance library by:
- Device category name in Korean
- Applicable MFDS product code (from the Classification Table)
- Relevant Act (Medical Devices Act vs IVD Act)