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Home-Use and Self-Test IVDs

IVDs for home use or self-testing require additional considerations:

  • Typically classified at Grade B or C (e.g., COVID-19 antigen self-tests at Grade C)
  • Lay user validation — validated for non-professionals without specialist training
  • IFU in simple, clear Korean with visual aids
  • Labelling must clearly state home/self-use and limitations

OTC availability​

OTC availability ​ Home-use IVDs may be supplied through different pathways based on risk classification and intended user: ​ • OTC (over-the-counter) via pharmacies: Grade A–B devices with simple operation and clear results (e.g., pregnancy tests, rapid COVID-19 antigen tests) • Pharmacy counter (with pharmacist consultation): Grade B–C devices requiring user education • Professional-only supply: Grade C–D devices or those requiring professional sample collection despite home administration ​ The MFDS 품목허가 explicitly designates the approved supply pathway; marketing outside this pathway constitutes a regulatory violation.

Regulatory pathway ​ Home-use IVDs typically require a 품목허가 (product license) submission. The STED must demonstrate that lay users can safely and effectively perform the test without professional supervision. Manufacturers should provide evidence of user comprehension studies or usability testing with the target lay population.

IFU requirements ​ Korean-language IFU must include: step-by-step instructions with photographs or diagrams, clear identification of positive/negative/invalid results, troubleshooting guidance, storage conditions, shelf life, and safety warnings specific to lay users (e.g., when to seek professional medical advice). QR codes linking to video tutorials or online support are recommended.