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Korea · MFDS Device Registration

Full-Turnkey MFDS Regulatory Filings Across Class I–IV

Powered by our proprietary MFDS review database that compresses turnaround times to 1/5 and systematically prevents recurring deficiency cycles, we author compliant technical files, defend reviewer inquiries, and secure final import licenses.

Inquire About 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

Addressed complex optical safety testing queries to secure final MFDS Class III approval in 65 days.

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

First-Cycle Approval Validation via MFDS Schema & Precedent Data

100% Alignment Between Korean STED Claims & Raw Test Certificates

Engineered 4-Stage Workflow

A 4-Stage Pipeline from Source Intake to License Issuance

Step 01 / 04Stage Gate & Output

Confirmed Class/Track & Locked Source Dossier

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

Digital Dossier Compilation & Live License Baseline Management

Structured Korean STED & Predicate Compilation

Map global technical specs into standardized MFDS sections with zero copy-paste discrepancies.

Explore module

@Global Registration Tracking— Run "Structured Korean STED & Predicate Compilation" across our MFDS Device Registration 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· Confirmed Class/Track & Locked Source Dossier

Map global technical specs into standardized MFDS sections with zero copy-paste discrepancies. Registration status, expiry, and renewals

Open in Global Registration Tracking

Live RFI Response & SLA Clock Management

Track reviewer questions, technical responses, and statutory response clocks in one collaborative workspace.

Explore module

@Document Control— Run "Live RFI Response & SLA Clock Management" across our MFDS Device Registration 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· Digital License Baseline Archiving

Store approved specs, raw materials, and manufacturing sites in RIM to automate future change impact checks. Full document lifecycle with version control

Open in Document Control

Service Specification

Service Scope & Final Deliverables

Scope

We manage all regulatory documentation and official authority communications required for statutory MFDS / NIDS approval.

  • Full-scope drafting of statutory Korean Technical File / STED submission dossiers
  • Preclinical safety, EMC, biocompatibility, and bench test report alignment
  • Regulatory structuring of intended use, mechanism of action, and raw material files
  • Official electronic submission and tracking via MFDS regulatory portal
  • Comprehensive defense and evidence generation for reviewer deficiency letters

Deliverables

Tangible regulatory assets conferring statutory market authorization and defensible technical documentation.

  • Official MFDS Medical Device Approval License (Manufacturing / Importation)
  • Complete, fully compliant Korean Technical File / STED Submission Master Dossier
  • Formal Deficiency Response Dossiers and supporting scientific rationale packages
  • Post-market compliance baseline and change-management register
MFDS Device Registration — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1Full-scope drafting of statutory Korean Technical File / STED submission dossiers
ScopeScope 2Preclinical safety, EMC, biocompatibility, and bench test report alignment
ScopeScope 3Regulatory structuring of intended use, mechanism of action, and raw material files
ScopeScope 4Official electronic submission and tracking via MFDS regulatory portal
ScopeScope 5Comprehensive defense and evidence generation for reviewer deficiency letters
WorkflowStage 1: Technical Intake & Regulatory BaseliningIngest source DHF, foreign clearances, test reports, and specifications to align with MFDS review standards.
WorkflowStage 2: Technical File Authoring & Pre-CheckAuthor Korean regulatory documentation natively against statutory templates and cross-verify clinical evidence.
WorkflowStage 3: Official Electronic Portal SubmissionCompile and lodge the formal submission package through the MFDS portal and manage intake gate validations.
WorkflowStage 4: Deficiency Defense & License GrantAuthor legally and scientifically grounded deficiency responses to protect timelines and secure the final approval license.
DeliverablesDeliverable 1Official MFDS Medical Device Approval License (Manufacturing / Importation)
DeliverablesDeliverable 2Complete, fully compliant Korean Technical File / STED Submission Master Dossier
DeliverablesDeliverable 3Formal Deficiency Response Dossiers and supporting scientific rationale packages
DeliverablesDeliverable 4Post-market compliance baseline and change-management register

Frequently Asked Questions

Yes. An applicant must hold an MFDS medical device importer license. Foreign manufacturers without Korean subsidiaries utilize Leanabl’s KLH service.

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 Accelerate Your MFDS Product Approval?

Experience our next-generation regulatory system backed by a proprietary MFDS review database that cuts turnaround to 1/5 and systematically prevents recurring deficiency cycles.

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