Korea · HIRA & nHTA Diagnostic
HIRA Reimbursement Pathway Diagnostic & Market Access Strategy
Diagnose existing health technology status, nHTA mandates, benefit categories, and maximum reimbursement pricing prior to MFDS approval.
Domain Expertise
Deep regulatory authority across every medical device domain
SaMD · AI Digital Health
IEC 62304 · Software Lifecycle · MFDS AI/Big Data & DTx Guidance
Secured a dedicated consumable subcategory at 130% of standard pricing through early HIRA positioning.
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
HIRA Procedure/Material Fee Schedule DB & NECA NHTA Precedent Mapping
100% Upfront Simulation of HIRA Fee Codes, NECA NHTA Triggers & Ceiling Prices
Engineered 4-Stage Workflow
4-Stage Diagnostic Pipeline from Clinical Billing Scenario to Commercial Roadmap
Clinical Procedure Workflow, Target Specialties & Billing Model Locked
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
Lock HIRA/NECA Reimbursement Requirements Directly into Your MFDS Dossier Baseline
Target HIRA Billing Code ↔ MFDS Intended Use Wording Guardrail
Locks the exact Korean indication phrasing required to qualify for Existing Technology status or separate consumable reimbursement.
@Global Registration Tracking— Run "Target HIRA Billing Code ↔ MFDS Intended Use Wording Guardrail" across our HIRA & nHTA Diagnostic 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
Locks the exact Korean indication phrasing required to qualify for Existing Technology status or separate consumable reimbursement. Registration status, expiry, and renewals
NECA Systematic Review Literature & Endpoint Readiness Tracker
Tracks peer-reviewed clinical publication counts and comparative outcomes required for NECA HTA or HIRA value-based pricing.
@Requirements Management— Run "NECA Systematic Review Literature & Endpoint Readiness Tracker" across our HIRA & nHTA Diagnostic 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
Pre-stages HIRA Existing Technology Confirmation and pricing dossiers so commercial access filings launch the day MFDS approval is granted. Traceability from specification to verification
Service Specification
Service Scope & Final Deliverables
Scope
Map device use cases against statutory HIRA fee schedules to identify paths avoiding nHTA delays.
- Procedure Category — Existing, Novel, or Deferrable Health Technology
- Consumable Status — Separately billable, bundled, or non-reimbursable
- Expected Tariff — Projected maximum reimbursement ceiling range
Deliverables
Authoritative fast-track designation and integrated review deliverables accelerating clinical adoption and reimbursement.
- Innovative Medical Device Designation Application and technological novelty briefing book
- MFDS-HIRA-NECA Integrated Review & Evaluation application dossier
- NHTA deferral / Early Market Entry application and systematic clinical evidence dossier
- Post-market Real-World Evidence (RWE) clinical registry protocol and data collection plan
- Official Innovative Medical Device Certificate and MOHW/NECA early clinical use notification
| Category | Item / Milestone | Specification & Deliverable |
|---|---|---|
| Scope | Scope 1 | Procedure Category — Existing, Novel, or Deferrable Health Technology |
| Scope | Scope 2 | Consumable Status — Separately billable, bundled, or non-reimbursable |
| Scope | Scope 3 | Expected Tariff — Projected maximum reimbursement ceiling range |
| Workflow | 1. Procedure Mapping | Map device against HIRA tariff tables and consumable categories. |
| Workflow | 2. Pricing Modeling | Model price ceilings using statutory formula benchmarks. |
| Workflow | 3. Strategy Delivery | Deliver finalized market access and reimbursement memo. |
| Deliverables | Deliverable 1 | Innovative Medical Device Designation Application and technological novelty briefing book |
| Deliverables | Deliverable 2 | MFDS-HIRA-NECA Integrated Review & Evaluation application dossier |
| Deliverables | Deliverable 3 | NHTA deferral / Early Market Entry application and systematic clinical evidence dossier |
| Deliverables | Deliverable 4 | Post-market Real-World Evidence (RWE) clinical registry protocol and data collection plan |
| Deliverables | Deliverable 5 | Official Innovative Medical Device Certificate and MOHW/NECA early clinical use notification |
Frequently Asked Questions
Ready to Accelerate Your Korean Regulatory Pathway?
Built on our proprietary MFDS review database, our next-generation regulatory system compresses turnaround times to 1/5 and systematically prevents recurring deficiency cycles.