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Notification (품목신고) — Overview

품목신고 (Product Notification) is the pre-market pathway for Grade I and II devices (and IVD Grades A and B). It is faster and simpler than 품목허가, but still requires valid GMP and complete documentation.

Key difference from 품목허가​

품목신고 does not involve a full scientific review by MFDS before marketing. However, documentation must be accurate — false declarations can result in cancellation and penalties. MFDS may audit documentation post-notification.

Prerequisites​

  • Active KGMP / Foreign GMP certificate
  • Business licence (제조업 허가 or 수입업 허가)
  • Complete documentation prepared

Typical processing times​

GradeProcessing time
Grade I~5–10 business days
Grade II~10–20 business days
IVD Grade A~5–10 business days
IVD Grade B~10–20 business days

Relevant legislation​

  • Medical Devices Act, Article 6 · IVD Act, Article 7