HIRA β Health Insurance Review and Assessment
HIRA (Health Insurance Review and Assessment Service, 건κ°λ³΄νμ¬μ¬νκ°μ) reviews health insurance claims and assesses the clinical value and cost-effectiveness of healthcare technologies, including medical devices.
MFDS vs HIRAβ
| Aspect | MFDS | HIRA |
|---|---|---|
| Role | Safety and effectiveness β legal market access | Reimbursement β NHI coverage |
| Requirement | Mandatory for ALL medical devices | Required only for NHI reimbursement |
| Data focus | Safety, technical, clinical evidence | Clinical effectiveness, cost-effectiveness |
HIRA assessment processβ
- Submit coverage application to HIRA after MFDS νλͺ©νκ°
- HIRA reviews clinical evidence for the device's clinical effectiveness
- HIRA evaluates cost-effectiveness (often requiring health economic analysis)
- NHIS sets the reimbursement price based on HIRA recommendation
New Technology Assessment (μ μλ£κΈ°μ νκ°)β
Truly novel devices not fitting an existing reimbursement category must go through HIRA's New Technology Assessment before NHI listing is possible. This adds typically 1β2 years to the market access timeline.