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.

Variant devices and model coverage

A single 품목허가 may cover multiple device models or variants if they share the same intended use, design principle, and safety/performance profile. Acceptable variants within one license include: (1) different sizes or lengths (e.g., catheter diameters 4 Fr to 8 Fr); (2) different material options with equivalent biocompatibility profiles; and (3) different connector types or accessories. However, substantial design changes, different operating principles, or changes in intended patient population typically require a separate 품목허가. Manufacturers must clearly document the rationale for grouping variants in the STED's Device Description section. If MFDS determines that variants are insufficiently similar, a deficiency notice may require separate submissions.