National Health Insurance Coverage and Listing
Korea has a National Health Insurance (NHI) system administered by the National Health Insurance Service (NHIS). Device reimbursement (급여 등재) is managed by HIRA (Health Insurance Review and Assessment Service) and is separate from MFDS 품목허가.
The two-step process
| Step | Authority | Purpose |
|---|---|---|
| MFDS 품목허가 | MFDS | Legal authority to sell the device in Korea |
| NHI listing | HIRA / NHIS | Authorization for NHI reimbursement |
For most devices, NHI listing is commercially critical — most Korean hospital purchases rely on NHI reimbursement.
How to apply for NHI listing
- Obtain MFDS 품목허가
- Submit NHI coverage application to HIRA
- HIRA evaluates clinical effectiveness and cost-effectiveness
- NHIS determines the reimbursement price
- If approved, device is listed in the NHI benefit schedule
Related pages
Timeline and Costs
The NHI listing process typically takes:
- 3–6 months for standard devices with established evidence packages
- 6–12 months for devices requiring health economic analysis
- 1–2+ years for truly novel devices requiring New Technology Assessment
Manufacturers should budget for submission fees to HIRA and may need to engage health economics consultants to prepare cost-effectiveness analyses required for Korean reimbursement.