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IFU and Package Insert Requirements

Required IFU Content​

All IFU and package insert materials must be in Korean. The following information is mandatory:

  • Product name and description
  • Intended use and indications
  • Contraindications
  • Warnings and precautions
  • Instructions for use / operation
  • Cleaning, disinfection, and sterilisation instructions (if applicable)
  • Maintenance instructions
  • Storage conditions
  • Disposal instructions
  • Technical specifications
  • Symbols and abbreviations legend
  • Information on accessories
  • Manufacturer / importer contact details

Professional vs patient-use IFU​

  • Professionally-used devices — technical language acceptable
  • Home-use / patient-use devices — plain language required; visual aids recommended

Add: 'While IFU must be in Korean, MFDS may permit supplementary foreign language versions (such as English) to accompany the Korean IFU for international users or healthcare professionals, provided the Korean version remains the primary instructional document.'