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Korea · Korea License Holder (KLH)

Independent Korea License Holder (In-Country Caretaker Service)

Retain 100% IP control and commercial freedom by holding MFDS product registrations through an independent, neutral regulatory entity.

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Domain Expertise

Deep regulatory authority across every medical device domain

SaMD · AI Digital Health

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

Rescued MFDS licenses from an underperforming distributor into Leanabl KLH, expanding to 3 specialist partners.

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

100% Transparent Control Over Customs EDI, IMDIS UDI & Statutory Logs

Zero Distributor Lock-In · Multi-Distributor EDI Clearance & Neutral Asset Custody

Engineered 4-Stage Workflow

A 4-Stage Pipeline from KLH Appointment to Ongoing Market Operations

Step 01 / 04Stage Gate & Output

Signed KLH Mandate & Quality Technical Agreement (QTA)

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

Real-Time Headquarters Visibility via Leanabl RIM & UDI Workspace

Headquarters-Controlled License & Dossier Vault

Access every MFDS license, STED technical file, and KGMP certificate held on your behalf in real time.

Explore module

@Global Registration Tracking— Run "Headquarters-Controlled License & Dossier Vault" across our Korea License Holder (KLH) 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· Signed KLH Mandate & Quality Technical Agreement (QTA)

Access every MFDS license, STED technical file, and KGMP certificate held on your behalf in real time. Registration status, expiry, and renewals

Open in Global Registration Tracking

Multi-Distributor EDI & Lot Traceability Ledger

Track every shipment clearance, incoming inspection sign-off, and distributor handoff with an immutable audit trail.

Explore module

@UDI Management— Run "Multi-Distributor EDI & Lot Traceability Ledger" across our Korea License Holder (KLH) 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 UDI Management records & 14 regulatory clauses

P1 · Verified Agent Output· Automated Statutory Reporting & Renewal Calendar

Never miss monthly IMDIS supply filings, annual KMDIA volume declarations, 3-year KGMP audits, or 5-year renewals. UDI-DI/PI data with GUDID and EUDAMED tracking

Open in UDI Management

Service Specification

Service Scope & Final Deliverables

Scope

Full regulatory stewardship and legal license ownership independent of local commercial distributors.

  • Statutory holding of MFDS medical device product licenses and import establishment license
  • Issuance and revocation of revocable distributor authorization letters under manufacturer control
  • Tracking of license renewal deadlines and statutory annual quality reporting
  • Management of medical device Unique Device Identification (UDI) data and supply reporting
  • Representation before MFDS for regulatory inquiries, inspections, and safety notifications

Deliverables

Tangible legal documentation and ongoing compliance records verifying secure regulatory tenure in Korea.

  • Official MFDS medical device product license certificates held under Leanabl stewardship
  • Annual compliance milestone calendar with statutory renewal and reporting deadlines
  • Manufacturer-controlled Distributor Authorization Certificates
  • Annual Quality System Reports and UDI database registration confirmations
  • Quarterly regulatory status briefings and complete MFDS correspondence logs
Korea License Holder (KLH) — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1Statutory holding of MFDS medical device product licenses and import establishment license
ScopeScope 2Issuance and revocation of revocable distributor authorization letters under manufacturer control
ScopeScope 3Tracking of license renewal deadlines and statutory annual quality reporting
ScopeScope 4Management of medical device Unique Device Identification (UDI) data and supply reporting
ScopeScope 5Representation before MFDS for regulatory inquiries, inspections, and safety notifications
WorkflowStage 1: Appointment & Regulatory Power of AttorneyExecute the KLH agreement and formalize the Power of Attorney to decouple regulatory authority from sales.
WorkflowStage 2: Technical Dossier Intake & License Transfer/FilingExecute smooth license transfer from incumbent distributor or register new products under Leanabl stewardship.
WorkflowStage 3: Controlled Distributor Authorization & Logistics SetupIssue revocable distributor authorizations and establish customs and import clearance interfaces.
WorkflowStage 4: Perpetual Regulatory Lifecycle OversightManage annual compliance calendar, renewals, change notifications, UDI maintenance, and MFDS communications.
DeliverablesDeliverable 1Official MFDS medical device product license certificates held under Leanabl stewardship
DeliverablesDeliverable 2Annual compliance milestone calendar with statutory renewal and reporting deadlines
DeliverablesDeliverable 3Manufacturer-controlled Distributor Authorization Certificates
DeliverablesDeliverable 4Annual Quality System Reports and UDI database registration confirmations
DeliverablesDeliverable 5Quarterly regulatory status briefings and complete MFDS correspondence logs

Frequently Asked Questions

Never. Leanabl is a pure regulatory holding entity and maintains zero commercial interest in margins, sales, or pricing.

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 Secure Independent Regulatory Ownership in Korea?

Speak with Leanabl specialists to establish a distributor-neutral KLH structure backed by our licensed MFDS importer infrastructure.

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