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Korea · License Renewal

Preemptive 5-Year Medical Device License Renewal Management

Secure seamless 5-year license renewals under tightened MFDS rules, verifying updated standards, 5-year commercial history, and vigilance data.

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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

Bridged testing gaps to the 3.2 edition through engineering justifications, securing clean 5-year renewal.

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

Portfolio Expiry Scanning & 5-Year Safety/Import Record Reconciliation

100% Statutory Window Compliance & 5-Year Evidence Verification

Engineered 4-Stage Workflow

A 4-Stage Pipeline from Portfolio Audit to Renewed 5-Year License

Step 01 / 04Stage Gate & Output

Portfolio Expiry Map & Keep/Prune SKU Decision

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

Zero-Lapse License Lifecycle Automation on Leanabl RIM

Automated D-365 / D-270 / D-180 Watchdog Alerts

Synchronize product license and KGMP renewal clocks with automated escalation before statutory windows open.

Explore module

@Global Registration Tracking— Run "Automated D-365 / D-270 / D-180 Watchdog Alerts" across our License Renewal 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· Portfolio Expiry Map & Keep/Prune SKU Decision

Synchronize product license and KGMP renewal clocks with automated escalation before statutory windows open. Registration status, expiry, and renewals

Open in Global Registration Tracking

Continuous 5-Year Import & PMS Evidence Aggregation

Automatically compile annual KMDIA import declarations and vigilance logs into renewal-ready dossier packets.

Explore module

@Document Control— Run "Continuous 5-Year Import & PMS Evidence Aggregation" across our License Renewal 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· Pre-Renewal Change Control Routing

Route any configuration or labeling drift found during pre-renewal checks directly into change notifications before filing. Full document lifecycle with version control

Open in Document Control

Service Specification

Service Scope & Final Deliverables

Scope

Comprehensive management of renewal prerequisites to prevent sudden market exit and sales interruptions.

  • Tracking 5-year expiration dates across all registered product licenses
  • Verification of annual production and import performance records submitted to KMDIA
  • Compilation of post-market safety data, vigilance reports, recalls, and foreign safety alerts
  • Review of compliance with updated technical standards and regulatory criteria
  • Preparation and formal submission of MFDS renewal dossiers within statutory windows

Deliverables

Official regulatory approvals and consolidated evidence securing your Korean market authorization for another 5 years.

  • Comprehensive 5-Year Portfolio Renewal Audit & Schedule
  • Production/Import Performance & Safety Evidence Compilation Binder
  • Complete MFDS License Renewal Submission Dossier
  • Official Electronic Filing Receipt verifying statutory compliance
  • Renewed Medical Device License Certificate with 5-year extension
License Renewal — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1Tracking 5-year expiration dates across all registered product licenses
ScopeScope 2Verification of annual production and import performance records submitted to KMDIA
ScopeScope 3Compilation of post-market safety data, vigilance reports, recalls, and foreign safety alerts
ScopeScope 4Review of compliance with updated technical standards and regulatory criteria
ScopeScope 5Preparation and formal submission of MFDS renewal dossiers within statutory windows
WorkflowStage 1: Expiration Audit & Eligibility AssessmentScreen portfolio expiration dates 12 months in advance and verify prerequisite commercial performance.
WorkflowStage 2: Performance & Safety Evidence CompilationConsolidate mandatory annual sales records, PMS data, adverse event summaries, and technical evidence.
WorkflowStage 3: Renewal Dossier Preparation & E-FilingDraft and file the renewal application within the statutory window (270 to 180 days prior to expiry).
WorkflowStage 4: Agency Review Management & License ExtensionResolve reviewer deficiency letters and obtain the renewed license with an extended 5-year validity.
DeliverablesDeliverable 1Comprehensive 5-Year Portfolio Renewal Audit & Schedule
DeliverablesDeliverable 2Production/Import Performance & Safety Evidence Compilation Binder
DeliverablesDeliverable 3Complete MFDS License Renewal Submission Dossier
DeliverablesDeliverable 4Official Electronic Filing Receipt verifying statutory compliance
DeliverablesDeliverable 5Renewed Medical Device License Certificate with 5-year extension

Frequently Asked Questions

While active sales are legally required, exceptions exist for orphan devices or documented supply disruptions if supported by statutory justification memos.

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.

Approaching Your 5-Year MFDS License Renewal Window?

Contact Leanabl to audit your renewal schedule and bridge updated technical standards with zero validity gaps.

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