Korea Reimbursement
MFDS Approval Gets You Into Korea. HIRA Listing Gets You Into Hospitals.
When Korea Reimbursement Is the Right Fit.
Three scenarios where foreign manufacturers lose 12–18 months on Korea's reimbursement track.
Pre-Approval Reimbursement Strategy
Class II–IV MFDS submission in flight — HIRA prep in parallel, not waiting on license to start the 12–24 month track.
New Technology HIRA Listing
Class III–IV device fitting no NHI category — new-technology HIRA listing built from clinical evidence forward.
Post-Rejection HIRA Re-Application
HIRA application rejected — grounds analysis, Korean RWE supplementation, re-submission engineered for committee scrutiny.
Every Deliverable Required to Secure a HIRA Reimbursement Listing.
Three coordinated services that produce and defend a HIRA-listed reimbursement code.
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Reimbursement Pathway Confirmation
Written determination — new-technology HIRA listing or existing NHI category — with regulatory rationale.
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HTA Criteria Mapping
HIRA evaluation criteria, NHI cost-effectiveness thresholds, and Korean epidemiology benchmarks for your device category.
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Clinical Evidence Gap Assessment
Audit of existing Phase III, RWE, and meta-analysis data — what applies directly and what needs Korean RWE supplementation.
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HTA Dossier Preparation
HIRA-formatted dossier: clinical evidence narrative, cost-effectiveness model, comparator analysis, Korean-language package.
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HIRA Submission & Committee Response Management
HIRA gateway filing, supplemental evidence responses, and committee correspondence managed through listing confirmation.
HIRA Listings Secured for Medical Devices in Multiple Categories.
New Technology HIRA Listing for a Class III Cardiovascular Device
HIRA Re-Application After Initial Rejection for a Diagnostic Device
Frequently Asked Questions
Common questions answered.
A HIRA Dossier Structured for Evaluation Approval and a Listed Reimbursement Code.
HIRA dossiers built from first principles — evidence mapped to evaluator criteria, engineered for committee scrutiny.
Speak with a HIRA Reimbursement Strategist Today