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HIRA Reimbursement Listing: 4-Phase Process from MFDS to Hospital

6 min read

HIRA (Health Insurance Review & Assessment Service) listing is what gets your device into Korean hospitals. Here's the 4-phase process and typical timelines.

Stephen JeongFounder, Leanabl Inc.
HIRA Reimbursement Listing: 4-Phase Process from MFDS to Hospital

Why HIRA Listing Matters

Without HIRA listing:

  • Device is legal to sell (MFDS approved) but hospitals avoid it
  • Patients must pay out-of-pocket
  • Limited hospital adoption
  • Korean revenue significantly lower than MFDS approval suggests

With HIRA listing:

  • NHI reimbursement available
  • Hospital procurement easier
  • Patient access broader
  • Revenue potential realized

The 4-Phase Process

Phase 1: Pre-Submission Strategy (Months 1–2)

Activities:

  • Reimbursement category determination
  • Benchmark device pricing analysis
  • Korean clinical evidence review
  • Submission strategy selection (existing category vs new category)

Decision points:

  • Category strategy: Map device to existing HIRA category (faster) or apply for new category (slower)
  • Pricing strategy: Equivalence to existing or premium with clinical justification
  • Health economics evidence: Required for new category or premium pricing

Phase 2: Submission Preparation (Months 2–5)

Documentation required:

  • MFDS approval certificate (KMD)
  • Korean clinical evidence
  • Health economics analysis (for premium pricing or new category)
  • Korean hospital usage projections
  • International reimbursement comparison
  • Manufacturing cost transparency (for some categories)

Submission package:

  • HIRA application form
  • Supporting clinical literature
  • Korean health economics model (if applicable)
  • Pricing justification
  • Reference letter from Korean KOL (helpful)

Phase 3: HIRA Review (Months 5–14)

Review process:

  1. Initial completeness review (4–6 weeks)
  2. Technical review (2–4 months)
  3. Clinical committee review (1–2 months)
  4. Economic evaluation review (2–3 months, if applicable)
  5. Final committee decision (1 month)

Possible outcomes:

  • Approved at proposed price
  • Approved at adjusted price (negotiation)
  • Approved as separate code with different reimbursement
  • Approved as combination with existing code
  • Rejected (rare for MFDS-approved devices)
  • Conditional approval pending additional evidence

Phase 4: Listing Decision (Month 14–18)

If approved:

  • Reimbursement code assigned
  • Effective date (typically 60–90 days post-decision)
  • Public notification in HIRA database
  • Hospital procurement enablement

If rejected or conditional:

  • Appeal process (3–6 months)
  • Additional evidence submission
  • Re-submission strategy

Reimbursement Categories

HIRA classifies medical devices into categories:

Category Examples Reimbursement Model
Treatment Materials Implants, sutures, catheters Per-procedure with consumable code
Diagnostic Equipment Imaging accessories Per-procedure with equipment factor
In Vitro Diagnostics Test kits, reagents Per-test with reagent code
Other Devices Various Procedure-specific

Each category has distinct submission requirements and review pathways.

Pricing Strategy

Strategy 1: Equivalence to Existing Category

  • Device categorized as substantially equivalent to listed devices
  • Pricing based on existing reimbursement
  • Fastest path (6–10 months)
  • Lower commercial flexibility

Strategy 2: Premium with Clinical Justification

  • Device offers clinical advantage over existing listings
  • Premium pricing requires health economics evidence
  • Longer timeline (10–18 months)
  • Higher revenue potential if approved

Strategy 3: New Reimbursement Category

  • Device represents new technology not fitting existing categories
  • New category creation required
  • Longest timeline (12–24 months)
  • High strategic value if approved

NECA Health Technology Assessment

For some devices, NECA (National Evidence-based Healthcare Collaborating Agency) Health Technology Assessment (HTA) is required before HIRA listing.

HTA triggers:

  • Novel technology with limited Korean clinical evidence
  • High-cost devices
  • New reimbursement category requests
  • AI/ML or digital health novel devices

HTA process:

  • Adds 6–12 months
  • Korean clinical evidence preparation
  • Cost-effectiveness analysis
  • Clinical effectiveness review

Most devices avoid NECA HTA by aligning with existing categories.

Common HIRA Submission Mistakes

Mistake 1: Filing Without Korean Clinical Evidence

International clinical data alone often insufficient. Korean patient population evidence strengthens submission.

Fix: Korean clinical evidence (literature or registry data) prepared pre-submission.

Mistake 2: Premium Pricing Without Economics Evidence

Asking for premium reimbursement without health economics justification.

Fix: Cost-effectiveness analysis required for premium pricing requests.

Mistake 3: Misaligned Category Selection

Choosing wrong category complicates review and adoption.

Fix: Pre-submission consultation with Korean health economics expert.

Mistake 4: Underestimating Timeline

Planning HIRA timeline as 6 months; actual takes 12+ months.

Fix: Plan 9–15 months base case; budget for delays.

Mistake 5: No Korean KOL Engagement

Submission lacks Korean clinical community endorsement.

Fix: Korean KOL engagement during submission preparation.

Cost Estimates

Component Cost Range
HIRA submission consulting $30K–$80K
Korean clinical evidence preparation $20K–$100K
Health economics analysis $30K–$150K
Korean KOL engagement $10K–$30K
Translation and documentation $5K–$15K
Total $95K–$375K

For high-value devices with significant Korean market potential, HIRA investment ROI is typically positive within 18–24 months of listing.

Frequently Asked Questions

Q: Is HIRA listing required to sell in Korea?

A: No. MFDS approval is the regulatory requirement; HIRA listing is for reimbursement. Without HIRA, sales possible but limited to private payment or self-pay segments.

Q: How long after MFDS approval should we file HIRA?

A: Typically file HIRA within 3–6 months of MFDS approval to enable hospital adoption planning.

Q: Can our distributor handle HIRA submission?

A: Distributors typically lack HIRA submission expertise. Specialized consultants or in-house Korean health economics team handles this.

Q: What if HIRA rejects our submission?

A: Appeal process available; re-submission with strengthened evidence common. Outright rejections rare for MFDS-approved devices.

Q: Does Leanabl help with HIRA?

A: Yes. Leanabl's HIRA Reimbursement Submission and Korea Reimbursement services cover HIRA strategy and submission.

How Leanabl Helps

Contact Leanabl for HIRA strategy.

Last updated: 2026-05-15.

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