What is an IVD Device?
An in vitro diagnostic (IVD) medical device is any medical device — including reagents, calibrators, instruments, and software — 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 (체외진단의료기기법) 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