IFU and Package Insert Requirements
Required IFU content (in Korean)
- 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
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