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Device Classification Notification

The MFDS Medical Device Classification Notification (의료기기 품목 및 품목별 등급에 관한 규정) is the central reference for device classification in Korea.

What it contains​

  • A comprehensive list of device types organised by body system and function
  • For each device type: assigned Grade (I–IV), definition, and applicable technical standards
  • Classification criteria for novel devices not yet listed

How to use it​

  1. Search by product type at udiportal.mfds.go.kr
  2. Identify the product code and assigned Grade
  3. The Grade determines the pre-market pathway and requirements

Finding the notification text​

  • law.go.kr — search: 의료기기 품목 및 품목별 등급