Korea · Digital & AI Positioning
Regulatory Strategy Under the 2025 Digital Medical Products Act
Position AI/ML SaMD, DTx, and generative health algorithms under Korea's landmark Digital Medical Products Act with Predetermined Change Control Plans (PCCP).
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 early PCCP approval enabling quarterly algorithm retraining deployments without repeated filings.
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
Korea Digital Medical Products Classification DB & Innovative Track Mapping
100% Upfront Mapping of Digital Medical Products Act, Wellness Boundaries & AI Fast-Tracks
Engineered 4-Stage Workflow
4-Stage Positioning Pipeline from Algorithm Decomposition to Fast-Track Blueprint
Algorithm I/O, UI Screens & Clinical Decision Support (CDSS) Level Audited
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 SaMD Positioning Directly to IEC 62304, PCCP & Integrated Review Workflows
Feature-Level Wellness vs. Regulated SaMD Claim Guardrails
Prevents UI copy or app release updates from inadvertently crossing into unapproved higher-risk medical device claims.
@Requirements Management— Run "Feature-Level Wellness vs. Regulated SaMD Claim Guardrails" across our Digital & AI Positioning 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
Prevents UI copy or app release updates from inadvertently crossing into unapproved higher-risk medical device claims. Traceability from specification to verification
Predetermined Change Control Plan (PCCP) & Model Version Traceability
Links AI retraining boundaries and validation protocols to PLM change control for seamless post-approval model updates.
@Risk Management— Run "Predetermined Change Control Plan (PCCP) & Model Version Traceability" across our Digital & AI Positioning 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
Centralizes clinical improvement justifications and technical novelty evidence for Korea’s inter-agency fast track. ISO 14971 risk register linked to design control
Service Specification
Service Scope & Final Deliverables
Scope
Classify software as digital medical devices, digital combination products, or digital health devices for optimal market paths.
- Classification — Class II/III SaMD determination under the Digital Act
- Software Norm — IEC 62304 and IEC 82304-1 health software compliance
- PCCP Protocol — Algorithm variance boundaries and re-validation criteria
Deliverables
Complete digital health and DTx integrated review deliverables securing simultaneous regulatory approval and temporary reimbursement.
- MFDS-HIRA-NECA One-Stop Integrated Review application dossier for AI/DTx devices
- Comprehensive clinical and academic evidence dossier for digital medical device evaluation
- Temporary reimbursement coding (selective coverage / non-covered) and health-economic value dossier
- Hospital EMR integration and patient adherence Real-World Data (RWD) tracking plan
- Official Integrated Review clearance notice and MOHW temporary reimbursement listing gazette
| Category | Item / Milestone | Specification & Deliverable |
|---|---|---|
| Scope | Scope 1 | Classification — Class II/III SaMD determination under the Digital Act |
| Scope | Scope 2 | Software Norm — IEC 62304 and IEC 82304-1 health software compliance |
| Scope | Scope 3 | PCCP Protocol — Algorithm variance boundaries and re-validation criteria |
| Workflow | 1. Architecture Audit | Audit data pipelines, model topologies, and cloud stacks. |
| Workflow | 2. Dataset Validation | Validate ground truth labeling and demographic variance. |
| Workflow | 3. PCCP Formulation | Deliver finalized PCCP and integrated fast-track dossier. |
| Deliverables | Deliverable 1 | MFDS-HIRA-NECA One-Stop Integrated Review application dossier for AI/DTx devices |
| Deliverables | Deliverable 2 | Comprehensive clinical and academic evidence dossier for digital medical device evaluation |
| Deliverables | Deliverable 3 | Temporary reimbursement coding (selective coverage / non-covered) and health-economic value dossier |
| Deliverables | Deliverable 4 | Hospital EMR integration and patient adherence Real-World Data (RWD) tracking plan |
| Deliverables | Deliverable 5 | Official Integrated Review clearance notice and MOHW temporary reimbursement listing gazette |
Frequently Asked Questions
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Built on our proprietary MFDS review database, our next-generation regulatory system compresses turnaround times to 1/5 and systematically prevents recurring deficiency cycles.