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How Classification Works β€” Korea's 4-Grade System

Korea uses a risk-based 4-grade classification system for medical devices. MFDS publishes a comprehensive Classification Table (λΆ„λ₯˜ κ³ μ‹œ) listing product types with their assigned grade.

Steps to classify a device​

  1. Search the MFDS Classification Table by product type at udiportal.mfds.go.kr
  2. Confirm the assigned Grade (I, II, III, or IV)
  3. If unlisted, submit a product classification inquiry (λΆ„λ₯˜ 민원) to MFDS

Risk factors considered​

  • Duration and degree of patient contact (transient / short-term / long-term)
  • Degree of invasiveness (non-invasive β†’ invasive β†’ implantable)
  • Whether the device delivers energy to the patient
  • Potential consequences of device failure

Relevant legislation​

  • Medical Devices Act, Articles 2–3
  • MFDS Notification β€” Medical Device Classification and Grade Assignment