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.
Korea's national health insurance system covers the vast majority of hospital purchases. A device not listed on the HIRA reimbursement schedule is effectively locked out of the mainstream hospital market. The listing process requires a specialized dossier, health economic justification, and negotiation with the HIRA committee — expertise that goes far beyond standard regulatory filing.
From application dossier to confirmed reimbursement code.
We combine regulatory depth with health economics expertise to navigate the HIRA committee process and secure a listing that reflects the true value of your device.
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.
- HIRA application dossier with clinical and economic evidence
- Health technology assessment (HTA) summary
- Economic justification report
- Pricing strategy memo and negotiation record
- HIRA listing confirmation and official reimbursement code
A device approved by MFDS but not listed on HIRA is a device the Korean market cannot access at scale.
We combine regulatory depth with health economics expertise to navigate the HIRA committee process and secure a listing that reflects the true clinical and economic value of your device — unlocking the full hospital purchasing volume Korea offers.
Speak with a HIRA Listing Specialist TodayFrequently Asked Questions
Common questions about HIRA reimbursement listing in Korea.