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How Classification Works — Korea's 4-Grade System

Korea uses a risk-based 4-grade classification system for medical South (Grades I–IV) devices under the Medical Devices Act. MFDS publishes a comprehensive Classification Table (분류 고시) 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 (분류 민원) to MFDS

Risk factors considered​

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

Relevant legislation​

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

Note: IVD devices are classified under a separate system (Grades A–D) rather than the standard Grades I–IV. See IVD classification for details.