Skip to main content

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 or approach not previously approved in Korea action, or novel manufacturing processes)
  • 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

Designation decision and appeal ​ MFDS typically decides on the innovative medical device designation application within 30 days of submission. If denied, the applicant may: — Request written rationale for denial — Resubmit with additional evidence of innovation — Proceed with standard 품목허가 pathway without the priority review benefits