Standard Hardware Device Strategy Will Fail MFDS SaMD Review. Korea Has Its Own Requirements.
MFDS has published standalone guidance for SaMD, AI/ML-enabled devices, and digital health products that diverges meaningfully from IEC 62304, ISO 14971, and FDA SaMD frameworks. Three deficiency cycles — common for SaMD first-time filers — means 12 to 18 months of pure delay.
A Korea SaMD Submission Built From the MFDS Guidance Document Outward.
We start from MFDS-published SaMD, AI/ML, and cybersecurity guidance and build your technical documentation to satisfy Korea-specific review criteria.
Regulatory Pathway Strategy + Technical File Gap Analysis
Confirming MFDS device classification for your SaMD, identifying the applicable guidance documents, and auditing your existing technical documentation against Korea's SaMD-specific requirements before any authoring begins.
Cybersecurity Documentation + Usability Engineering
Preparing the cybersecurity documentation structured to MFDS guidance — threat modeling, security control documentation, vulnerability management procedures — and executing or documenting usability validation to Korean-language interface and user population requirements.
Risk Management Documentation + Technical Documentation & Registration
Building the Korea-specific risk management file with software hazard analysis and traceability matrix, integrating all components into the MFDS STED format, and managing the full submission and deficiency response lifecycle.
SaMD Deficiency Cycles Are Not Recoverable on a Standard Launch Timeline.
Korea-Specific Cybersecurity Documentation
We structure your cybersecurity documentation specifically to Korea's medical device cybersecurity guidance — not simply adapted from CE MDR or FDA frameworks — covering threat modeling, security controls, and vulnerability management in the format MFDS reviewers examine.
Korean User Population Usability Validation
MFDS requires usability validation documented with Korean-language interfaces and Korean user populations. We prepare or document this validation to the exact format MFDS reviewers flag most frequently — preventing the most common SaMD deficiency trigger.
SaMD Approvals for AI/ML and Digital Health Manufacturers.
Class II AI Diagnostic SaMD Approval for a North American Digital Health Company
Built the complete MFDS technical package — cybersecurity documentation, Korean usability file, and risk management file with traceability matrix — for an AI-powered diagnostic SaMD, achieving first-cycle MFDS approval without deficiency.
Post-Market Algorithm Update Protocol for a European AI/ML Device
Established an MFDS-aligned algorithm change management protocol for a European manufacturer's AI/ML device, enabling post-market algorithm updates without triggering full re-submission requirements.
Your MFDS SaMD Approval Certificate and Defensible Technical Package.
A SaMD company that enters MFDS review without Korea-specific cybersecurity documentation and a proper usability file is submitting an incomplete file that MFDS has no choice but to reject.
Speak with a SaMD Regulatory Specialist TodayFrequently Asked Questions
Common questions answered.