In Vitro Diagnostics Medical Devices Act (체외진단의료기기법)
The In Vitro Diagnostics Medical Devices Act (체외진단의료기기법), enacted 2019 and effective May 2021, is a separate primary statute governing IVD devices in Korea.
Why a separate IVD Act?
IVDs operate on patient specimens outside the body and produce diagnostic information rather than directly treating patients — requiring tailored regulation. Korea followed the global trend (similar to the EU's separate IVDR) of enacting dedicated legislation.
Key provisions
| Article | Subject |
|---|---|
| Article 2 | Definitions — IVD, manufacturer, Grades A/B/C/D |
| Article 6 | IVD grade classification |
| Article 7 | 품목허가 / 품목신고 for IVDs |
| Article 15 | IVD manufacturer licence |
| Article 22 | IVD GMP requirements |
| Article 27 | IVD labelling |
| Article 31 | IVD adverse event reporting |
Transition from Medical Devices Act
IVD products approved under the Medical Devices Act before May 2021 were required to transition to the IVD Act regime. Most transition periods have now ended.
Official source
law.go.kr — search: 체외진단의료기기법