MFDS Product License Renewal: 90-Day Pre-Expiry Checklist
Korean medical device licenses require renewal every 3 years. Missing renewal results in license expiry and market withdrawal. Here's the 90-day pre-expiry checklist.
Why Renewal Matters
Korean Medical Device Law requires periodic renewal of all medical device product licenses (KMD). The renewal verifies:
- Continued compliance with current MFDS requirements
- Ongoing post-market obligations performance
- Updated technical and labeling documentation
- KGMP certificate validity (if Class II+)
- KLH information accuracy
Failure to renew = license expiry = product cannot be legally sold in Korea.
The 3-Year Renewal Cycle
| Year | Activity |
|---|---|
| Year 1 | KMD issued; routine post-market obligations |
| Year 2 | Continued post-market obligations; KGMP surveillance audit |
| Year 3 (Month 30+) | Renewal preparation begins |
| Year 3 (Month 33+) | Renewal filing submitted |
| Year 3 (Month 36) | Renewal expected approved; new KMD issued |
90-Day Pre-Expiry Checklist
Day 90 (3 Months Before Expiry)
KGMP Status Verification:
- Verify KGMP certificate valid through renewal date and beyond
- If KGMP renewal due soon, coordinate with product license renewal
- Confirm KGMP surveillance audits complete
Post-Market Compliance Audit:
- Review adverse event reporting record (last 3 years)
- Confirm vigilance reporting timely (5/15/30 day compliance)
- Verify change notifications up to date
- Confirm CAPA records complete
Documentation Currency:
- Korean STED current with any approved changes
- Labels and IFU reflect current MFDS requirements
- Risk management file updated
Day 60 (2 Months Before Expiry)
Renewal Application Preparation:
- KLH information confirmation (legal entity, address, contact)
- Manufacturer information confirmation (legal entity, address, manufacturing site)
- KMD number and product details verification
- Sales volume report (last 3 years)
Updated Documents:
- Adverse event summary report
- Significant change summary (changes filed during license period)
- Post-market literature review summary
- Korean clinical updates (if relevant)
Day 30 (1 Month Before Expiry — Filing Deadline)
Filing Activities:
- Renewal application submitted via MFDS electronic system
- MFDS official fees paid (~$1,500 Class II, $4,500 Class III/IV)
- Filing acceptance confirmation received
- Internal records updated with renewal filing number
Day 0 (Expiry Date)
If renewal filed on time:
- License remains valid pending renewal review (typically 30–60 days)
- Continue normal market operations
- Monitor MFDS response
If renewal NOT filed:
- License expires — product cannot be sold legally
- Re-registration required (4–9 months)
- Market gap during re-registration
What Triggers Renewal Difficulty
Issue 1: Outstanding Adverse Events Without Resolution
MFDS reviews vigilance compliance during renewal. Open serious adverse events without CAPA resolution can delay renewal.
Fix: Resolve all outstanding events 60 days before renewal filing.
Issue 2: Unfiled Changes
Changes implemented in field without MFDS change notification surface during renewal.
Fix: Audit change records 90 days before renewal; file backlog changes via License Compliance Update before renewal.
Issue 3: KGMP Expired or Lapsed
If KGMP certificate expired or under surveillance findings, renewal may be conditional.
Fix: KGMP and product license renewal cycles aligned (or KGMP renewed 6 months ahead).
Issue 4: Labeling Non-Compliance
Labels outdated relative to current MFDS labeling rules (MFDS Notice 2022-110).
Fix: Pre-renewal labeling audit; update labels before filing.
Issue 5: KLH Capacity Issues
If KLH has changed or KLH's MFDS standing has issues.
Fix: KLH continuity verification 90 days before renewal.
License Expiry Consequences
If renewal missed:
| Consequence | Impact |
|---|---|
| License expires automatically | Product cannot be sold |
| Re-registration required | 4–9 months process |
| Re-registration fees | $3K–$15K (same as initial) |
| KGMP re-verification needed | Potential additional inspection |
| Korean labeling redo | New KMD number means new labels |
| Distribution gap | Lost revenue during re-registration |
| Customer notification | Hospitals require re-qualification |
Total cost of missed renewal: $50K–$300K + 6+ month market gap.
Best Practice: 180-Day Renewal Calendar
Calendar reminders 180 days, 120 days, 90 days, 60 days, 30 days before expiry.
180-day check: Initial KGMP/KMD status review. 120-day check: Vigilance and change record audit. 90-day check: Full renewal preparation start (this checklist). 60-day check: Document finalization. 30-day check: Filing deadline.
What MFDS Reviews During Renewal
MFDS renewal review covers:
| Area | Documents |
|---|---|
| Continued compliance | Vigilance record, change notifications |
| Manufacturing | KGMP certificate, surveillance audit reports |
| Documentation | Current STED, labels, IFU |
| Sales | 3-year sales volume report |
| KLH | KLH information confirmation |
Review typically 30–60 days. Renewal extension granted automatically while review pending.
Cost of Renewal
| Component | Class I | Class II | Class III/IV |
|---|---|---|---|
| MFDS official fees | ~$220 | ~$1,500 | ~$4,500 |
| KLH renewal coordination | $1K–$3K | $1K–$3K | $1K–$3K |
| Documentation update | $2K–$5K | $3K–$8K | $5K–$15K |
| Pre-renewal audit | $2K–$5K | $3K–$8K | $5K–$10K |
| Total Renewal | $5K–$13K | $8K–$20K | $15K–$33K |
Frequently Asked Questions
Q: Can we delay renewal past the deadline?
A: No. Filing must be before expiry. If filed within 30 days of expiry, license remains valid pending review. After expiry without filing, re-registration required.
Q: Can renewal be denied?
A: Rarely (<5% of cases) when documentation complete. Most denials trace to outstanding regulatory issues.
Q: What if our manufacturing site changed during the license period?
A: Site changes require change notification before renewal. New site requires KGMP certificate.
Q: How does Leanabl handle renewals?
A: Leanabl's License Renewal Management service tracks all client licenses and manages renewals proactively. Typical renewal coordination begins 180 days before expiry.
Q: Can we renew multiple licenses at once?
A: Each license renews on its own 3-year cycle. Portfolio management consolidates filing logistics.
How Leanabl Helps
- License Renewal Management — proactive renewal management
- Korea License Maintenance — ongoing license operations
- Korea Post-Market Operations — portfolio-wide license management
- License Compliance Update — pre-renewal change backlog cleanup
Contact Leanabl for renewal management.
Last updated: 2026-05-15.
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