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 categoriesβ
- Devices designated as innovative medical devices (νμ μλ£κΈ°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
Benefitsβ
- Shortened target review timelines (approximately 50% faster than standard)
- Dedicated MFDS review team
- Enhanced pre-submission consultation support
Applicationβ
Apply for fast-track status alongside the νλͺ©νκ° application via the MFDS eSubmission portal. Justify eligibility based on innovation status, public health need, or rare disease indication.