MFDS Approval Gets You Into Korea. HIRA Listing Gets You Into Korean Hospitals.
Reimbursement listing under Korea's National Health Insurance system is a separate regulatory track requiring a distinct dossier. Manufacturers who begin HIRA preparation only after obtaining their MFDS license have already surrendered 12 to 18 months of preparation lead time.
A HIRA Dossier Built for Health Technology Assessment — Not Repurposed From Registration Data.
We build the reimbursement case from the clinical evidence outward — starting with the HIRA evaluation criteria and working backward to identify what data you have, what you need, and how to present it.
HIRA Reimbursement Listing + Clinical Evidence Strategy
Confirming the reimbursement pathway (new technology listing vs. existing coverage category), identifying HIRA-applicable HTA criteria, and structuring your clinical evidence — existing trial data, real-world evidence, or meta-analysis — into a HIRA-ready argument before dossier preparation begins.
Regulatory Intelligence / Monitoring
Tracking HIRA evaluation guidelines, NHI coverage policy updates, and competitor reimbursement listing activity in your device category — providing your commercial and clinical teams with the intelligence needed to make evidence generation and commercial positioning decisions.
Promotional Material Review
Reviewing Korea-facing promotional materials against MFDS promotional regulations before market deployment, ensuring that claims made in physician-facing materials are consistent with the approved MFDS indication and HIRA reimbursement scope.
The Difference Between a 12-Month HIRA Evaluation and a 24-Month One Is Almost Always the Quality of the Dossier at First Submission.
Clinical Evidence Built During Registration Phase
We begin building the clinical evidence strategy and HTA arguments during MFDS registration — not after license issuance — so that your HIRA preparation has a 12-to-18-month head start over manufacturers who wait.
First-Cycle Approval Strategy
HIRA does not evaluate on an open timeline — evaluation windows open and close. We structure dossiers from first principles to pass committee scrutiny the first time, avoiding the 18-month cycle loss that an incomplete first submission causes.
HIRA Listings Secured for Medical Devices in Multiple Categories.
New Technology HIRA Listing for a Class III Cardiovascular Device
Structured the clinical evidence strategy, prepared the HTA dossier, and secured HIRA new technology listing for a Class III cardiovascular implant — with the first submission achieving approval without supplemental evidence requests.
HIRA Re-Application After Initial Rejection for a Diagnostic Device
Analyzed the rejection grounds for a European in-vitro diagnostic manufacturer, supplemented the clinical evidence with Korean real-world evidence, and achieved HIRA listing on re-application within 18 months of the initial rejection.
A HIRA Dossier Structured for Evaluation Approval and a Listed Reimbursement Code.
Leanabl structures HIRA dossiers from first principles: we identify what HIRA evaluators require, build the clinical evidence narrative to meet those criteria, and prepare the dossier to survive committee scrutiny.
Speak with a HIRA Reimbursement Strategist TodayFrequently Asked Questions
Common questions answered.