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Device Description and Intended Use

The device description and intended use section is the foundation of the STED.

Required content​

  • Product name (Korean and English)
  • Product code (MFDS Classification Table code)
  • Intended use (사용 목적) — precise statement of purpose, patient population
  • Indications for use and contraindications
  • Principle of operation
  • Physical, functional, and technical description
  • All models, sizes, variants
  • Accessories and components

Why intended use matters in Korea​

The 품목허가 is granted specifically for the stated intended use. Marketing outside the approved use is a regulatory violation. Keep the intended use precise and clinically meaningful.