What MFDS Counts as a Reportable Change: 2026 Threshold Update
MFDS change notification rules determine which device modifications require re-filing. The 2026 threshold updates affect software updates, labeling changes, and manufacturing process modifications.
Why Change Classification Matters
Misclassifying a change has consequences:
- Under-reporting: MFDS audit findings, potential license suspension
- Over-reporting: Unnecessary filing fees, delays, administrative burden
The right classification depends on the change's effect on device safety, performance, intended use, or essential design.
The Three Change Tiers
Tier 1: Minor Changes (No Notification Required)
Changes that do not affect safety, performance, or intended use.
Examples:
- Spelling corrections in non-regulatory documents
- Cosmetic packaging changes (color, font without label content change)
- Minor software UI improvements without algorithm change
- Manufacturing site internal procedure refinements (no process change)
- Administrative document updates
Action required: Document in internal change log per Korean Medical Device Law. No MFDS filing.
Tier 2: Notification-Required Changes (변경신고/변경허가)
Changes affecting non-essential aspects of safety, performance, or labeling.
Examples:
- Manufacturing site address change (same site)
- Korean labeling text updates
- IFU clarifications without indication change
- Accessory additions
- Software updates without algorithm or intended use changes
- Packaging materials change without sterility impact
- Supplier change for non-critical components
Filing requirements:
- Change notification application within 30 days of change implementation
- Updated documentation for affected sections
- MFDS official fee: ₩500K–₩2M ($370–$1.5K)
- MFDS review: 30–60 days
Tier 3: Re-Registration Required (신규허가)
Changes affecting essential design, intended use, performance, or safety.
Examples:
- New indications added
- Patient population change
- Algorithm change for AI/ML SaMD
- Manufacturing site change (different site)
- Sterilization method change
- Material change for patient-contacting components
- Performance specification change beyond MFDS tolerance
- Classification change
Filing requirements:
- Full new registration submission required
- New KGMP inspection (if manufacturing site changes)
- MFDS official fees: ₩4M–₩20M ($3K–$15K)
- MFDS review: 60+ days (II), 6–12 months (III–IV)
2026 Threshold Updates: Key Changes
MFDS 2026 guidance update clarifies previously ambiguous areas:
Software Updates
| Change Type | 2024 Classification | 2026 Classification |
|---|---|---|
| Bug fixes without functional change | Internal log | Internal log (unchanged) |
| Security patches (CVE fixes) | Often unclear | Notification required |
| UI improvements without algorithm change | Internal log | Internal log (unchanged) |
| Algorithm parameter tuning within PCCP | New registration | Notification (if within pre-approved PCCP) |
| Algorithm replacement | New registration | New registration (unchanged) |
| New AI/ML training data (within PCCP) | New registration | Notification (if within pre-approved PCCP) |
The PCCP-based notification path is new in 2026 and aligns Korean rules with FDA approach for AI/ML devices.
Labeling Changes
| Change Type | Classification |
|---|---|
| MFDS-mandated warning updates | Notification |
| Korean language clarifications | Notification |
| Accessory list updates | Notification |
| Storage condition clarifications | Notification |
| New indication added to label | New registration |
| Off-label use additions | New registration |
Manufacturing Process
| Change Type | Classification |
|---|---|
| Equipment refresh (same process) | Internal log |
| Process parameter optimization (within validated range) | Internal log |
| New equipment validated with same process | Notification |
| Process change (e.g., new sterilization method) | New registration |
| Manufacturing site change | New registration + new KGMP |
Common Misclassification Patterns
Pattern 1: Software Updates Underreported
Foreign manufacturers often classify all software updates as "internal log" without considering Korean-specific implications.
Risk: If a software update affects clinical decision support, alarm thresholds, or data integrity, MFDS may classify it as notification-required even if the manufacturer considers it minor.
Fix: Korean software change committee should review every release for MFDS classification.
Pattern 2: Korean Labeling Changes Over-Reported
Conversely, some manufacturers file change notifications for every minor Korean labeling text update.
Risk: Unnecessary filing fees and administrative burden. Some changes (translation corrections without content change) qualify as internal log.
Fix: Establish clear criteria for which labeling changes require notification.
Pattern 3: Supplier Changes Underreported
Changing a supplier for sterilization indicator strips might seem minor, but if the supplier change affects sterility validation, MFDS classifies it as notification-required.
Fix: Map supplier changes to product safety/performance impact before classifying.
Pattern 4: AI/ML PCCP Confusion
Many manufacturers without an MFDS-approved PCCP classify every model update as new registration. With a PCCP, updates within scope are notification-only.
Fix: Establish MFDS PCCP early for AI/ML devices to enable notification-based updates.
Change Management Workflow
For Korean post-market obligations:
Step 1: Change Identification
- Engineering or quality team identifies proposed change
- Change description documented
- Affected device(s) identified
Step 2: Classification Assessment
- Korean regulatory function reviews change
- Classification per 3 tiers above
- Decision documented with rationale
Step 3: Filing Preparation (if Tier 2 or 3)
- Updated technical documentation prepared
- Korean translations completed
- KLH coordination for filing
Step 4: MFDS Filing
- Notification or new registration filed via KLH
- MFDS official fees paid
- Filing tracking initiated
Step 5: MFDS Approval and Implementation
- Wait for MFDS clearance (30–60 days notification, 60+ days registration)
- Implementation hold until approval
- Updated labeling and documentation deployed
Step 6: Post-Implementation Verification
- Confirm change implemented per approval
- Update internal change log
- Inform KLH for ongoing maintenance
Frequently Asked Questions
Q: What if we implement a change before MFDS approval?
A: Tier 2 changes (notification) must be filed within 30 days of implementation; pre-implementation approval is not strictly required but recommended. Tier 3 changes (new registration) must be approved before market implementation — pre-approval distribution is illegal.
Q: How does Leanabl help with change classification?
A: Leanabl's Change Notification Management service includes change classification review, filing preparation, and post-market change tracking.
Q: Can we appeal MFDS classification decisions?
A: MFDS classification is generally not appealable, but pre-submission consultation can clarify expectations. If a change is rejected, response with additional justification is possible.
Q: What about pending changes during license renewal?
A: Outstanding change notifications should be resolved before license renewal filing. Pending changes can complicate renewal review.
Q: How long does change notification take vs new registration?
A: Notification: 30–60 days. New registration: 60+ days (Class II) or 6–12 months (Class III–IV). Change notification is preferred when scope allows.
How Leanabl Helps
- Change Notification Management — change classification and filing
- Korea Design Lock — design freeze with regulatory in the room
- Korea License Maintenance — ongoing change management
Contact Leanabl for change management consultation.
Last updated: 2026-05-15.
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