HIRA Reimbursement
Insurance Listing Is Where Korean Market Revenue Is Won or Lost.
Without HIRA listing, Korean hospitals cannot reimburse your device — and most will not buy it.
Without HIRA listing, a device is locked out of the mainstream Korean hospital market. The dossier, economic justification, and committee negotiation require expertise beyond standard regulatory filing.
Dossier Preparation
We compile the full HIRA application — including clinical evidence review, health technology assessment (HTA) support, and economic justification — structured to meet HIRA committee review standards.
Pricing Strategy & Negotiation
We advise on reimbursement pricing strategy, prepare the negotiation dossier, and represent your position through the HIRA pricing committee process to achieve a commercially viable listing price.
Listing Management
We manage all HIRA correspondence, track listing status, and handle any re-evaluation or pricing renegotiation requirements after initial listing is confirmed.
Your Complete HIRA Listing Package
All documentation and outcomes needed to achieve and maintain HIRA reimbursement listing.
Frequently Asked Questions
Common questions about HIRA reimbursement listing in Korea.
A device approved by MFDS but not listed on HIRA is a device the Korean market cannot access at scale.
Regulatory depth + health economics. A listing that reflects your device's true clinical and economic value — unlocking Korea's hospital volume.
Speak with a HIRA Listing Specialist Today