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National Health Insurance Coverage and Listing

Korea has a National Health Insurance (NHI) system administered by the National Health Insurance Service (NHIS). Device reimbursement (κΈ‰μ—¬ λ“±μž¬) is managed by HIRA (Health Insurance Review and Assessment Service) and is separate from MFDS ν’ˆλͺ©ν—ˆκ°€.

The two-step process​

StepAuthorityPurpose
MFDS ν’ˆλͺ©ν—ˆκ°€MFDSLegal authority to sell the device in Korea
NHI listingHIRA / NHISAuthorization for NHI reimbursement

For most devices, NHI listing is commercially critical β€” most Korean hospital purchases rely on NHI reimbursement.

How to apply for NHI listing​

  1. Obtain MFDS ν’ˆλͺ©ν—ˆκ°€
  2. Submit NHI coverage application to HIRA
  3. HIRA evaluates clinical effectiveness and cost-effectiveness
  4. NHIS determines the reimbursement price
  5. If approved, device is listed in the NHI benefit schedule

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.