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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 (ν˜μ‹ μ˜λ£ŒκΈ°κΈ°)
  • 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 β€” 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 ν’ˆλͺ©ν—ˆκ°€ 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 β€” ideally at pre-submission consultation or when submitting the ν’ˆλͺ©ν—ˆκ°€ application. Late requests may not be accommodated for the current review cycle.