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Fast-Track Review Program

MFDS has introduced a fast-track review program for certain medical devices to reduce review timelines for innovative or urgently needed products.

Eligible device categories​

  • Devices designated as innovative medical devices (혁신의료기기)
  • Devices addressing public health emergencies (e.g., devices approved for emergency use during COVID-19)
  • Devices for rare diseases or unmet medical needs with limited treatment options

Benefits​

  • Shortened target review timelines — typically 30–50% reduction compared to standard review pathways, with specific timelines determined during pre-submission consultation
  • Dedicated MFDS review team
  • Enhanced pre-submission consultation support

Application​

Apply for fast-track status alongside the 품목허가 application via the MFDS eSubmission portal. Justify eligibility based on innovation status, public health need, or rare disease indication.

Timing of fast-track application ​ Fast-track status should be requested early — ideally at pre-submission consultation or when submitting the 품목허가 application. Late requests may not be accommodated for the current review cycle.

Fast-track review timelines are typically: Grade III devices reduced to 2–4 months (versus standard 3–6 months), and Grade IV devices reduced to 4–8 months (versus standard 6–12 months). Timelines are confirmed during pre-submission consultation. Fast-track status does not exempt devices from complete technical documentation or risk management requirements—only the MFDS review timeline is accelerated.