Korea · Regulatory Strategy
Definitive Korean Market Entry Regulatory Roadmap
Lock in MFDS classification, predicate equivalence, testing scope, and KGMP audit tracks upfront to eliminate regulatory risk and sunk costs.
Domain Expertise
Deep regulatory authority across every medical device domain
SaMD · AI Digital Health
IEC 62304 · Software Lifecycle · MFDS AI/Big Data & DTx Guidance
Prevented Class III re-classification by establishing valid predicate equivalence, reducing approval time by 8 months.
Active Devices · Robotics
IEC 60601-1 / 60601-1-2 (Ed. 4.1) · IEC 60601-2-XX Particular Standards
Architected regulatory positioning under the Digital Medical Products Act, unlocking expedited integrated review.
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
Empirical Validation via Predicate & Regulatory Databases
100% Cross-Validated Predicate & Classification Intelligence
Engineered 4-Stage Workflow
A Standardized 4-Stage Pipeline from Intake to Masterplan
Locked Technical Baseline & Intended Use
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
From Static Strategy Decks to Live Platform Execution
Automated Requirement Traceability
Directly link confirmed regulatory standards and testing requirements into PLM and risk management modules.
@Requirements Management— Run "Automated Requirement Traceability" across our Regulatory Strategy 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
Directly link confirmed regulatory standards and testing requirements into PLM and risk management modules. Traceability from specification to verification
Structured Predicate & Dossier Seeding
Convert validated equivalence matrices directly into pre-populated technical submission templates.
@Risk Management— Run "Structured Predicate & Dossier Seeding" across our Regulatory Strategy 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 Risk Management records & 14 regulatory clauses
Monitor testing, GMP, and submission dependencies in one unified RIM workspace with zero handoff loss. ISO 14971 risk register linked to design control
Service Specification
Service Scope & Final Deliverables
Scope
We establish regulatory qualification, classification, the optimal submission track, and core evidentiary requirements.
- Regulatory qualification — medical device / IVD / digital health (SaMD)
- Target classification and grade, combination-device and kit determination
- Submission track and reviewing body — notification, certification, approval, or expedited pathways
- Predicate device identification and technical equivalence comparison
- Clinical evidence exemption analysis and testing gap assessment (performance, electrical, biocompatibility, cybersecurity)
Deliverables
Every conclusion cites regulatory statutes and predicate precedents, delivered in an executive summary and technical dossier.
- Regulatory qualification determination memo and classification review
- Predicate device equivalence matrix and benchmark report
- Submission pathway decision table and expedited-track eligibility assessment
- Evidence requirement gap matrix and testing checklist
- Step-by-step commercial timeline, itemized budget estimate, and regulatory risk register
| Category | Item / Milestone | Specification & Deliverable |
|---|---|---|
| Scope | Scope 1 | Regulatory qualification — medical device / IVD / digital health (SaMD) |
| Scope | Scope 2 | Target classification and grade, combination-device and kit determination |
| Scope | Scope 3 | Submission track and reviewing body — notification, certification, approval, or expedited pathways |
| Scope | Scope 4 | Predicate device identification and technical equivalence comparison |
| Scope | Scope 5 | Clinical evidence exemption analysis and testing gap assessment (performance, electrical, biocompatibility, cybersecurity) |
| Workflow | Stage 1: Technical Intake & Architecture Freeze | Lock down intended use, mechanism of action, materials, sterility, and software architecture through in-depth technical review. |
| Workflow | Stage 2: Regulatory Cross-Validation | Interrogate target regulatory databases (MFDS, FDA, EU MDR), statutory classification rules, and predicate equivalence with senior peer review. |
| Workflow | Stage 3: Pathway & Evidence Sequencing | Map submission tracks, laboratory testing lead times, clinical evidence thresholds, GMP inspection timing, and reimbursement milestones chronologically. |
| Workflow | Stage 4: Executive Masterplan & Briefing | Deliver the decision-ready Pathway Report detailing classification, predicate defense, itemized budget, and conduct leadership briefing for sign-off. |
| Deliverables | Deliverable 1 | Regulatory qualification determination memo and classification review |
| Deliverables | Deliverable 2 | Predicate device equivalence matrix and benchmark report |
| Deliverables | Deliverable 3 | Submission pathway decision table and expedited-track eligibility assessment |
| Deliverables | Deliverable 4 | Evidence requirement gap matrix and testing checklist |
| Deliverables | Deliverable 5 | Step-by-step commercial timeline, itemized budget estimate, and regulatory risk register |
Frequently Asked Questions
Ready to Accelerate Your Korean Regulatory Pathway?
Built on our proprietary MFDS review database, our next-generation regulatory system compresses turnaround times to 1/5 and systematically prevents recurring deficiency cycles.