Korea · Clinical Trial Exemption
Defensible Clinical Trial Exemption & Predicate Equivalence Strategy
Synthesize foreign clinical trials, predicate literature, and non-clinical benchmarks to establish legal exemptions from costly domestic trials.
Domain Expertise
Deep regulatory authority across every medical device domain
SaMD · AI Digital Health
IEC 62304 · Software Lifecycle · MFDS AI/Big Data & DTx Guidance
Secured full Class III approval without domestic trials using pre-clinical data and 12 peer-reviewed studies.
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
MFDS Cleared Predicate DB & Substantial Equivalence (SE) Comparison Engine
100% Statutory Mapping of MFDS 4-Factor Substantial Equivalence & Literature Exemptions
Engineered 4-Stage Workflow
4-Stage Pipeline from Predicate Discovery to Confirmed Clinical Exemption
Device Mechanism & Claims Analyzed; Korean Predicate Candidates 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
Connect Predicate Equivalence Assets Directly to Korean STED & Change Control
Direct Sync: Substantial Equivalence Matrix ↔ Korean STED Dossier
Populates MFDS comparison tables and performance test baselines directly into your Korean Technical File registration workspace.
@Requirements Management— Run "Direct Sync: Substantial Equivalence Matrix ↔ Korean STED Dossier" across our Clinical Trial Exemption 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
Populates MFDS comparison tables and performance test baselines directly into your Korean Technical File registration workspace. Traceability from specification to verification
Structured Foreign Clinical & SCI Literature Evidence Vault
Archives GCP certificates, statistical plans, and peer-reviewed papers with full traceability to MFDS review criteria.
@Document Control— Run "Structured Foreign Clinical & SCI Literature Evidence Vault" across our Clinical Trial Exemption 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
Evaluates future hardware or indication updates to ensure modifications stay within non-clinical SE boundaries. Full document lifecycle with version control
Service Specification
Service Scope & Final Deliverables
Scope
Map technical, biological, and clinical equivalence to domestic predicates to claim statutory trial exemptions.
- Statutory Review — Evaluation against MFDS Article 27 clinical exemption criteria
- Predicate Matrix — Comprehensive 1:1 comparative matrix against domestic predicates
- SLR Report — Systematic literature review report and clinical evaluation file
Deliverables
Definitive clinical regulatory deliverables securing MFDS IND approval, IRB clearance, and foreign clinical data bridging.
- MFDS-compliant Korean Clinical Investigation Plan (Protocol) and Statistical Analysis Plan (SAP)
- Investigator Brochure (IB), Informed Consent Form (ICF), and Case Report Form (CRF) package
- Foreign clinical data bridging and ethnic sensitivity evaluation report per ICH E5 / MFDS rules
- Official MFDS Investigational Medical Device Application (IND) Approval Letter and response dossier
- Clinical trial site IRB approval certificates and investigational device Korean labeling artworks
| Category | Item / Milestone | Specification & Deliverable |
|---|---|---|
| Scope | Scope 1 | Statutory Review — Evaluation against MFDS Article 27 clinical exemption criteria |
| Scope | Scope 2 | Predicate Matrix — Comprehensive 1:1 comparative matrix against domestic predicates |
| Scope | Scope 3 | SLR Report — Systematic literature review report and clinical evaluation file |
| Workflow | 1. Predicate Mapping | Isolate domestic predicates and build specification comparison matrices. |
| Workflow | 2. Literature Synthesis | Perform systematic literature extraction and statistical analysis. |
| Workflow | 3. Justification Dossier | Finalize official Clinical Trial Exemption Justification Memo. |
| Deliverables | Deliverable 1 | MFDS-compliant Korean Clinical Investigation Plan (Protocol) and Statistical Analysis Plan (SAP) |
| Deliverables | Deliverable 2 | Investigator Brochure (IB), Informed Consent Form (ICF), and Case Report Form (CRF) package |
| Deliverables | Deliverable 3 | Foreign clinical data bridging and ethnic sensitivity evaluation report per ICH E5 / MFDS rules |
| Deliverables | Deliverable 4 | Official MFDS Investigational Medical Device Application (IND) Approval Letter and response dossier |
| Deliverables | Deliverable 5 | Clinical trial site IRB approval certificates and investigational device Korean labeling artworks |
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.