Korea SaMD Approval
Hardware Strategy Fails MFDS SaMD Review. Korea Has Its Own Requirements.
When Korea SaMD Approval Is the Right Fit.
Three profiles where Korea's SaMD framework makes hardware-style approaches unrecoverable.
CE / FDA-Cleared SaMD Entering Korea
CE MDR or FDA-cleared SaMD needing MFDS-aligned cybersecurity and Korean usability — not a re-skinned file.
AI / ML-Enabled Device With Post-Market Updates
Algorithms updating post-market — MFDS AI/ML change-management protocol so updates avoid full re-submission.
Hybrid SaMD + Hardware Submission
Software paired with sensors or connected hardware — one integrated MFDS submission, not parallel files.
Every Deliverable Required to Hold a SaMD License in Korea.
Three coordinated services that produce and defend a SaMD-specific MFDS submission.
- / 01
MFDS SaMD Classification Confirmation
Written confirmation of MFDS class and applicable SaMD, AI/ML, and cybersecurity guidance.
- / 02
Korea-Specific SaMD Gap Analysis
Audit of CE MDR / FDA documentation against Korea's SaMD sections — flagging reusable, restructure, and new-content artifacts.
- / 03
Guidance Document Map
Each applicable MFDS guidance (classification, software lifecycle, cybersecurity, AI/ML, usability) tied to specific submission sections.
- / 04
Submission Strategy Brief
Pre-submission roadmap: anticipated deficiencies, MFDS reviewer expectations, projected timeline.
SaMD Approvals for AI/ML and Digital Health Manufacturers.
Class II AI Diagnostic SaMD Approval for a North American Digital Health Company
Post-Market Algorithm Update Protocol for a European AI/ML Device
Frequently Asked Questions
Common questions answered.
Your MFDS SaMD Approval Certificate and Defensible Technical Package.
Without Korea-specific cybersecurity and usability docs, an MFDS SaMD file is incomplete by definition.
Speak with a SaMD Regulatory Specialist Today