HIRA — Health Insurance Review and Assessment
HIRA (Health Insurance Review and Assessment Service, 건강보험심사평가원) reviews health insurance claims and assesses the clinical value and cost-effectiveness of healthcare technologies, including medical devices.
MFDS vs HIRA
| Aspect | MFDS | HIRA |
|---|---|---|
| Role | Safety and effectiveness — legal market access | Reimbursement — 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 process
- Submit coverage application to HIRA after MFDS 품목허가
- 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 (신의료기술평가)
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 1–2 years to the market access timeline.