Skip to main content

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.

Intended use precision examples ​ Overly broad (likely rejected): • "For diagnosis of infectious diseases" • "For general laboratory testing" ​ Precise and clinically meaningful: • "For in vitro diagnosis of COVID-19 infection via nasopharyngeal swab sample in symptomatic adults" • "For quantitative measurement of HbA1c in whole blood samples for diabetes management monitoring" ​ Precision prevents regulatory violations from off-label marketing and supports robust clinical evaluation.