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

Some home-use IVDs are authorised for OTC sale in pharmacies; others require professional involvement. The approved intended use specifies the supply pathway.