IVD Devices

IVD devices are regulated under the Diagnostic Device Act (진단용 의료기기 법) with a separate Grade A–D classification system based on risk of incorrect results. Key IVD-specific requirements:

Formal performance evaluation (not clinical evaluation) — analytical validation (sensitivity, specificity, accuracy) and clinical validity in the intended patient population Reference laboratories — for Grade C–D devices, results may require confirmation by MFDS-designated reference laboratories Companion diagnostics coordination with drug approval — IVDs used to select patients for specific drugs must align with drug approval timelines

• Formal performance evaluation (not clinical evaluation)
• Reference laboratories for certain confirmatory testing
• Companion diagnostics coordination with drug approval

Related pages

• IVD classification · Performance evaluation for IVDs · Companion diagnostics

IVD classification system ​ IVDs are classified A–D based on the risk of producing incorrect results: ​ • Grade A: minimal risk (general screening tests) • Grade B: low-to-moderate risk (most routine laboratory tests) • Grade C: moderate-to-high risk (confirmatory tests, pregnancy tests, blood grouping) • Grade D: highest risk (blood screening, HIV/hepatitis testing) ​ Higher grades require more robust performance evaluation and may require reference laboratory validation.