Medical Devices Act vs IVD Act — Which Applies?
Korea has two separate primary Acts governing medical products. Choosing correctly is the essential first step.
Decision logic
Is the product used outside the body to examine human specimens?
├─ YES → In Vitro Diagnostics Medical Devices Act (IVD Act)
└─ NO → Does it diagnose, treat, prevent, or alleviate disease/disability?
├─ YES → Medical Devices Act
└─ NO → Not a regulated medical device
Key differences
| Feature | Medical Devices Act | IVD Act |
|---|---|---|
| Classification grades | I, II, III, IV | A, B, C, D |
| Clinical evidence | Clinical evaluation / clinical trial | Performance evaluation / study |
| Effective date | Long established | May 2021 |
Combination products
Contact MFDS for a product determination when a device crosses both Acts.