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Korea · IVD Registration & Testing

Turnkey IVD Regulatory Approval & Clinical Performance Evaluation

Powered by our proprietary MFDS review database that compresses timelines to 1/5 and systematically prevents recurring deficiency cycles, we execute specialized IVD approvals covering analytical performance (LoD, precision, interference), stability, and university hospital IRB clinical performance studies (PPA/NPA).

Inquire About IVD 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 full Class III approval in 4 months by managing a 200-specimen clinical study at a leading hospital.

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

MFDS IVD Review Guideline & CLSI Analytical / Clinical Performance DB

100% Compliance with Korea IVD Act Class 1–4 Dossiers, CLSI Protocols & Clinical Performance

Engineered 4-Stage Workflow

4-Stage IVD Pipeline from Class/Assay Audit to MFDS IVD License & KGMP

Step 01 / 04Stage Gate & Output

Korea IVD Act Class (1–4) & Reagent/Calibrator/Instrument Architecture 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

Unify Multi-Lot Stability, CLSI Analytical Data & IVD Dossiers in Leanabl

Automated Mapping: CLSI Analytical Endpoints ↔ Korean IVD STED

Links LoD, precision, cross-reactivity, and stability reports directly to MFDS IVD technical file sections.

Explore module

@Requirements Management— Run "Automated Mapping: CLSI Analytical Endpoints ↔ Korean IVD STED" across our IVD Registration & Testing 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 Requirements Management records & 14 regulatory clauses

P1 · Verified Agent Output· Korea IVD Act Class (1–4) & Reagent/Calibrator/Instrument Architecture Locked

Links LoD, precision, cross-reactivity, and stability reports directly to MFDS IVD technical file sections. Traceability from specification to verification

Open in Requirements Management

Real-Time Shelf-Life Extension & Post-Approval Filing Tracker

Tracks ongoing real-time stability timepoints to trigger formal MFDS shelf-life extension amendments upon completion.

Explore module

@Document Control— Run "Real-Time Shelf-Life Extension & Post-Approval Filing Tracker" across our IVD Registration & Testing 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 Document Control records & 14 regulatory clauses

P1 · Verified Agent Output· Reagent-Analyzer Compatibility & Critical Raw Material Change Control

Assesses regulatory re-testing impact whenever antibodies, primers, enzymes, or compatible analyzer firmware change. Full document lifecycle with version control

Open in Document Control

Service Specification

Service Scope & Final Deliverables

Scope

Classify reagents across Class I–IV based on clinical criticality and configure the optimal authorization path.

  • Analytical — LoD, LoQ, repeatability, reproducibility, and interference
  • Clinical — Clinical sensitivity, specificity, PPA, NPA, and ROC analysis
  • Stability — Real-time, accelerated, and open-vial in-use stability files

Deliverables

Complete IVD analytical/clinical performance dossiers and official MFDS/NIDS licenses under the In Vitro Diagnostic Medical Devices Act.

  • In Vitro Diagnostic Medical Devices Act Class I–IV classification assessment and Korean IVD Technical File / STED
  • Analytical performance validation package (LoD, precision, linearity, cross-reactivity, stability)
  • Clinical performance study report and foreign clinical specimen data bridging justification
  • IVD-specific KGMP conformity application dossier and quality management system master file
  • Official MFDS / NIDS IVD Premarket Approval or Certification license and compliant Korean labeling
IVD Registration & Testing — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1Analytical — LoD, LoQ, repeatability, reproducibility, and interference
ScopeScope 2Clinical — Clinical sensitivity, specificity, PPA, NPA, and ROC analysis
ScopeScope 3Stability — Real-time, accelerated, and open-vial in-use stability files
Workflow1. Analytical DossierStandardize LoD, interference, and precision testing files.
Workflow2. Clinical Performance StudyExecute IRB clearances and compile diagnostic accuracy files.
Workflow3. MFDS Technical ReviewFile statutory submissions and defend technical deficiency rounds.
Workflow4. License IssuanceSecure and deliver official MFDS IVD product licenses.
DeliverablesDeliverable 1In Vitro Diagnostic Medical Devices Act Class I–IV classification assessment and Korean IVD Technical File / STED
DeliverablesDeliverable 2Analytical performance validation package (LoD, precision, linearity, cross-reactivity, stability)
DeliverablesDeliverable 3Clinical performance study report and foreign clinical specimen data bridging justification
DeliverablesDeliverable 4IVD-specific KGMP conformity application dossier and quality management system master file
DeliverablesDeliverable 5Official MFDS / NIDS IVD Premarket Approval or Certification license and compliant Korean labeling

Frequently Asked Questions

Yes, if conducted under GCP with validated ethnic equivalence, though high-risk Class III/IV assays often require confirmatory Korean residual specimen studies.

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 Complete Your IVD Registration Without Delays?

Backed by our proprietary MFDS review database, our next-generation system compresses turnaround to 1/5 and systematically prevents recurring deficiency cycles for IVD reagents and analyzers.

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