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Korea · HIRA Reimbursement

Turnkey HIRA Reimbursement Listing & NECA nHTA Execution

Immediately upon MFDS approval, we execute HIRA reimbursement applications, consumable price ceiling negotiations before the Expert Assessment Committee, and NECA nHTA filings to unlock hospital procurement.

Inquire About HIRA Reimbursement

Domain Expertise

Deep regulatory authority across every medical device domain

SaMD · AI Digital Health

IEC 62304 · Software Lifecycle · MFDS AI/Big Data & DTx Guidance

Defended superior clinical utility to secure the highest tariff ceiling in its category, 40% above predicates.

Active Devices · Robotics

IEC 60601-1 / 60601-1-2 (Ed. 4.1) · IEC 60601-2-XX Particular Standards

Essential Performance definition and worst-case test matrix optimization across accredited laboratories

Implants · Biomaterials

ISO 10993-1 to 23 Biocompatibility · ISO 11135 / 11137 Sterilization Validation

Biological endpoint matrix design and ISO 10993-18 chemical characterization / toxicological assessment

In Vitro Diagnostics (IVD)

Korea IVD Act & EU IVDR (2017/746) · CLSI EP Guidelines (EP05, EP06, EP12, EP17)

CLSI-compliant Limit of Detection (LoD), cross-reactivity, interference, and lot-to-lot reproducibility protocols

Proprietary Data & Precedent Validation

Empirical Pricing & Coding via HIRA Fee Schedules & NECA Precedents

100% Quantitative Mapping of HIRA Reimbursement Codes & Ceiling Prices

Engineered 4-Stage Workflow

A 4-Stage Pipeline from Pathway Triage to Official Gazette Listing

Step 01 / 04Stage Gate & Output

Locked HIRA/NECA Track & Target Price Band

Incomplete baseline data or misclassified regulatory pathways are the primary drivers of multi-month submission delays. Gate 01 locks the device scope, predicate/standard mapping, and full document inventory before authoring begins.

Verification Baseline

Device description, intended use, existing test reports, and QMS document index

Gate Sign-Off Output

Confirmed classification matrix and locked submission master inventory

Agentic Automation & Platform Integration

Synchronized Regulatory & Market Access Asset Management

License-to-Billing Code Traceability

Link approved MFDS model numbers and indications directly to HIRA reimbursement codes and hospital SKU lists.

Explore module

@Global Registration Tracking— Run "License-to-Billing Code Traceability" across our HIRA Reimbursement records and call out the highest-priority compliance findings first.

I'll inspect the linked quality and dossier records against target regulatory standards, then report actionable findings with verified outputs.

Thought for 4.2s · Explored Global Registration Tracking records & 14 regulatory clauses

P1 · Verified Agent Output· Locked HIRA/NECA Track & Target Price Band

Link approved MFDS model numbers and indications directly to HIRA reimbursement codes and hospital SKU lists. Registration status, expiry, and renewals

Open in Global Registration Tracking

Controlled Value-Appraisal Evidence Vault

Manage clinical literature, comparator matrices, and customs cost documentation with full version control.

Explore module

@Requirements Management— Run "Controlled Value-Appraisal Evidence Vault" across our HIRA Reimbursement records and call out the highest-priority compliance findings first.

I'll inspect the linked quality and dossier records against target regulatory standards, then report actionable findings with verified outputs.

Thought for 4.3s · Explored Requirements Management records & 14 regulatory clauses

P1 · Verified Agent Output· Post-Listing Tariff & Model-Addition Tracking

Monitor HIRA fee-schedule revisions, re-evaluations, and new model listing updates in one unified workspace. Traceability from specification to verification

Open in Requirements Management

Service Specification

Service Scope & Final Deliverables

Scope

Strategic classification, Health Technology Assessment (HTA), economic justification, and pricing negotiation for Korean national health insurance.

  • Predicate code matching, category assignment (reimbursed vs. non-reimbursed), and nHTA pathway review
  • Clinical literature synthesis and comparative efficacy benchmarking
  • Manufacturing cost breakdown and A8 international reference price benchmarking
  • Compilation of full submission dossiers for HIRA’s Medical Material Evaluation Committee
  • Negotiation of upper limit reimbursement prices with the Ministry of Health and Welfare (MOHW)

Deliverables

Complete health economics dossiers and official ministerial listing confirmations enabling Korean hospital billing.

  • HIRA Reimbursement Pathway & Pricing Strategy Roadmap
  • Health Technology Assessment (HTA) & Clinical Evidence Synthesis Report
  • Manufacturing Cost Analysis & Economic Justification Dossier
  • Official HIRA Submission Filings and Deficiencies Response Package
  • MOHW Promulgated Official EDI Reimbursement Code Confirmation
HIRA Reimbursement — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1Predicate code matching, category assignment (reimbursed vs. non-reimbursed), and nHTA pathway review
ScopeScope 2Clinical literature synthesis and comparative efficacy benchmarking
ScopeScope 3Manufacturing cost breakdown and A8 international reference price benchmarking
ScopeScope 4Compilation of full submission dossiers for HIRA’s Medical Material Evaluation Committee
ScopeScope 5Negotiation of upper limit reimbursement prices with the Ministry of Health and Welfare (MOHW)
WorkflowStage 1: Pathway Diagnosis & Evidence StrategyDetermine separate reimbursement eligibility, predicate codes, and need for New Health Technology Assessment.
WorkflowStage 2: Reimbursement Dossier & Economic ModelingSynthesize clinical endpoints, cost-effectiveness justifications, and cost breakdown disclosures.
WorkflowStage 3: Expert Committee Defense & Evidentiary SupplementationManage defense before HIRA’s evaluation committee and respond to pricing algorithm queries.
WorkflowStage 4: Upper Limit Price Agreement & EDI Code PromulgationFinalize commercially viable price ceiling and secure statutory EDI billing codes in the official gazette.
DeliverablesDeliverable 1HIRA Reimbursement Pathway & Pricing Strategy Roadmap
DeliverablesDeliverable 2Health Technology Assessment (HTA) & Clinical Evidence Synthesis Report
DeliverablesDeliverable 3Manufacturing Cost Analysis & Economic Justification Dossier
DeliverablesDeliverable 4Official HIRA Submission Filings and Deficiencies Response Package
DeliverablesDeliverable 5MOHW Promulgated Official EDI Reimbursement Code Confirmation

Frequently Asked Questions

Statutory review from HIRA application to Ministry of Health gazetting typically takes approximately 100 business days.

Upon receiving any deficiency notice from MFDS or a review body, our specialists dissect the reviewer’s statutory intent against historical clearance precedents. We separate items resolvable via technical justification from those requiring supplementary bench data, draft the complete formal response package, and manage reviewer alignment through final closure.

Yes. However, direct translation without regulatory reconciliation frequently triggers rejections due to standard edition mismatches or Korea National Deviations. We map your existing IECEE CB / ILAC test reports and global dossiers 1:1 against MFDS recognized standards to maximize evidence reuse and avoid redundant laboratory testing.

Our workflow is engineered to minimize engineering disruption. Once your team provides baseline source files (specifications, BOM, existing reports) during Stage 1 intake, Leanabl handles the heavy lifting: statutory mapping, Korean regulatory authoring, traceability matrix compilation, electronic portal filing, and agency correspondence. Your team only reviews and signs off at structured stage gates.

We immediately perform a regulatory change impact assessment to determine whether the modification requires a formal Technical File amendment, minor notification, or internal QMS documentation update. Because all deliverables are structured into modular digital assets, subsequent design iterations only require updating the affected sections rather than rebuilding the dossier from scratch.

Ready to Unlock Hospital Procurement with Optimal HIRA Reimbursement?

Backed by our proprietary regulatory and reimbursement database, we execute HIRA tariff listings and NECA nHTA filings with maximum speed.

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