| μλ£κΈ°κΈ° | Uiryo-gigi | Medical device |
| 체μΈμ§λ¨μλ£κΈ°κΈ° | Cheoewejindan uiryo-gigi | In vitro diagnostic medical device |
| μνμμ½νμμ μ² | Sikpum-uiyakpum-anjeoncheo | Ministry of Food and Drug Safety (MFDS) |
| νλͺ©νκ° | Pummok-heoga | Marketing Authorization |
| νλͺ©μ κ³ | Pummok-singo | Product Notification |
| μλ£κΈ°κΈ°λ² | Uiryo-gigi-beop | Medical Devices Act |
| 체μΈμ§λ¨μλ£κΈ°κΈ°λ² | β | IVD Medical Devices Act |
| μ μ‘°μ
νκ° | Jejoeo-eop heoga | Manufacturer licence |
| μμ
μ
νκ° | Suip-eop heoga | Importer licence |
| νκ΅ λλ¦¬μΈ | Hanguk daeriin | Korean agent |
| μ΄μμ¬λ‘λ³΄κ³ | Isang-sarye-bogo | Adverse event report |
| μ¬μ¬μ¬ | Jaesimsa | Re-examination |
| μ¬νκ° | Jaepyeongga | Re-evaluation |
| κ³ μ | Gosi | MFDS Notification |
| μ μλ―Όμ | Jeonja-minjwon | eSubmission portal |
| νμ μλ£κΈ°κΈ° | Hyeoksin uiryo-gigi | Innovative medical device (designation) |
| μμμν μΉμΈ | β | Clinical trial approval |
| KIMS | β | Korea Integrated Medical-device System |
| UDI-K | β | Korean Unique Device Identification |
| HIRA | β | Health Insurance Review & Assessment Service |