Innovative Medical Device Designation (혁신의료기기)
The Innovative Medical Device Designation (혁신의료기기) program allows devices meeting Korea's innovation criteria to benefit from a faster regulatory review pathway and dedicated MFDS support.
Eligibility criteria
A device may qualify as an innovative medical device if it:
- Uses novel technology (e.g., AI/ML, novel biomaterials, novel mechanisms of action)
- Has the potential to significantly improve treatment outcomes compared to existing treatments
- Addresses an unmet clinical need in Korea
Benefits of the designation
- Priority review — MFDS assigns dedicated reviewers and targets faster decision timelines
- Regulatory consultation — enhanced pre-submission meetings with MFDS
- Regulatory flexibility — MFDS may accept evolving evidence pathways for truly novel technologies
- Public recognition — designation is publicly announced on the MFDS website
How to apply
Submit a Innovative Medical Device Designation Application via the MFDS eSubmission portal before or alongside the 품목허가 application. Include:
- Device description and technology overview
- Evidence of innovation (comparison with existing treatments)
- Clinical rationale and unmet need statement