Leanabl Logo

Korea · UDI & Ad Compliance

Turnkey Monthly UDI Supply Reporting, Advertising Clearance & Regulatory Intelligence

Zero-error monthly NIDS UDI supply reporting retainers, pre-market advertising clearance from KMDIA, and proactive regulatory intelligence monitoring.

Inquire Now

Domain Expertise

Deep regulatory authority across every medical device domain

SaMD · AI Digital Health

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

Processed 5,000+ monthly SKU shipments with zero errors, passing unannounced NIDS audits cleanly.

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

IMDIS UDI / Supply Reporting Schema & Medical Device Act Art. 20–24 Labeling/Ad DB

100% Synchronization Across MFDS Licenses, IMDIS UDI, Korean Labels & Promotional Claims

Engineered 4-Stage Workflow

4-Stage Commercial Compliance Pipeline from Artwork Lock to Monthly IMDIS Operations

Step 01 / 03Stage Gate & Output

Korean Label Artwork, Packaging Hierarchy & IFU/e-IFU Baseline 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

Single-Source Synchronization Across MFDS License, Korean Labels, eIFU & IMDIS UDI

Single-Source Sync: MFDS License ↔ Korean Label Artwork ↔ IMDIS UDI

Automatically triggers Korean label artwork and IMDIS UDI updates whenever a license amendment alters models, claims, or site addresses.

Explore module

@UDI Management— Run "Single-Source Sync: MFDS License ↔ Korean Label Artwork ↔ IMDIS UDI" across our UDI & Ad Compliance 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 UDI Management records & 14 regulatory clauses

P1 · Verified Agent Output· Korean Label Artwork, Packaging Hierarchy & IFU/e-IFU Baseline Locked

Automatically triggers Korean label artwork and IMDIS UDI updates whenever a license amendment alters models, claims, or site addresses. UDI-DI/PI data with GUDID and EUDAMED tracking

Open in UDI Management

Automated Pre-Validation of Monthly IMDIS Supply Reports

Validates shipment logs (UDI-PI, lot/serial numbers, healthcare facility codes, quantities) before monthly IMDIS portal submission.

Explore module

@Admin Console & 4-Stage Release Workflow— Run "Automated Pre-Validation of Monthly IMDIS Supply Reports" across our UDI & Ad Compliance 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 Admin Console & 4-Stage Release Workflow records & 14 regulatory clauses

P1 · Verified Agent Output· Korean eIFU Version Control & 3-Year Ad Approval Expiry Tracking

Maintains compliant Korean e-IFU web distribution and tracks the 3-year statutory renewal cycle for KMDIA-approved promotional materials. Shared multi-SKU IFU mapping, 4-stage approval with self-approval block & hash-chain audit trail

Open in Admin Console & 4-Stage Release Workflow

Service Specification

Service Scope & Final Deliverables

Scope

Ingest raw ERP shipping logs, validate hospital codes, and complete official NIDS IMDIS submissions 10 days early.

  • UDI Filings — Monthly zero-error NIDS EDI supply chain submissions
  • Ad Review — Full management of KMDIA advertising panel applications
  • Intelligence — Monthly English executive regulatory intelligence reports

Deliverables

Complete commercial compliance deliverables securing IMDIS UDI registration, monthly supply reporting, and KMDIA advertising clearance.

  • SKU/packaging UDI barcode (GS1/HIBCC) mapping table and Article 20 compliant Korean label/IFU artworks
  • MFDS Integrated Medical Device Information System (IMDIS) UDI master data registration confirmations
  • Monthly medical device supply reporting (Article 31-2) validation logs and official filing receipts
  • Medical Device Act Articles 24 & 24-2 promotional copy legal review and redline audit report
  • Official KMDIA autonomous advertising pre-review approval certificates and registered review numbers
UDI & Ad Compliance — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1UDI Filings — Monthly zero-error NIDS EDI supply chain submissions
ScopeScope 2Ad Review — Full management of KMDIA advertising panel applications
ScopeScope 3Intelligence — Monthly English executive regulatory intelligence reports
Workflow1. Data Intake (10th)Receive raw shipping and invoice records from customer ERP.
Workflow2. Validation & Reformatting (15th)Reconcile hospital codes and validate barcode GTIN validity.
Workflow3. Official NIDS Filing (20th)Execute electronic submission to secure official NIDS confirmation.
DeliverablesDeliverable 1SKU/packaging UDI barcode (GS1/HIBCC) mapping table and Article 20 compliant Korean label/IFU artworks
DeliverablesDeliverable 2MFDS Integrated Medical Device Information System (IMDIS) UDI master data registration confirmations
DeliverablesDeliverable 3Monthly medical device supply reporting (Article 31-2) validation logs and official filing receipts
DeliverablesDeliverable 4Medical Device Act Articles 24 & 24-2 promotional copy legal review and redline audit report
DeliverablesDeliverable 5Official KMDIA autonomous advertising pre-review approval certificates and registered review numbers

Frequently Asked Questions

Yes. Full enforcement across all classes (including Class I) took effect in July 2024; all distribution must be reported monthly.

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 Offload Monthly UDI Filings & Advertising Clearances?

Engage Leanabl’s monthly compliance retainer for zero-error NIDS submissions, KMDIA ad approvals, and regulatory briefings.

Request Assessment