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Device Classification Notification

The MFDS Medical Device Classification Notification (์˜๋ฃŒ๊ธฐ๊ธฐ ํ’ˆ๋ชฉ ๋ฐ ํ’ˆ๋ชฉ๋ณ„ ๋“ฑ๊ธ‰์— ๊ด€ํ•œ ๊ทœ์ •) is the central reference for device classification in Korea.

What it containsโ€‹

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

How to use itโ€‹

  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 textโ€‹

  • law.go.kr โ€” search: ์˜๋ฃŒ๊ธฐ๊ธฐ ํ’ˆ๋ชฉ ๋ฐ ํ’ˆ๋ชฉ๋ณ„ ๋“ฑ๊ธ‰

Add under 'Classification criteria for novel devices not yet listed': "Manufacturers may request MFDS classification guidance for devices not explicitly listed. Submit a written inquiry with product description, intended use, risk profile, and proposed predicate devices. MFDS responds within 30 days with a preliminary classification recommendation. If disagreement remains, manufacturers may request formal reclassification review or appeal through administrative procedures."