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What is an IVD Device?

An in vitro diagnostic (IVD) medical device is any medical device β€” including reagents, calibrators, instruments, and software β€” intended for in vitro examination of human-derived specimens to provide information about physiological or pathological states, congenital abnormalities, treatment compatibility, or therapeutic monitoring.

Dedicated IVD Act​

Korea introduced the In Vitro Diagnostics Medical Devices Act (μ²΄μ™Έμ§„λ‹¨μ˜λ£ŒκΈ°κΈ°λ²•) effective May 2021, separating IVD regulation from the broader Medical Devices Act. IVD devices have their own 4-grade classification system (Grades A, B, C, D).

Relevant legislation​

  • In Vitro Diagnostics Medical Devices Act, Article 2