A Missed Renewal or Unfiled Change Notification Can Cancel a License That Took 18 Months to Earn.
MFDS product licenses do not self-renew. Each license carries a 5-year renewal deadline that, if missed, results in automatic cancellation — requiring full re-registration, not reinstatement.
A Managed Compliance Retainer That Owns Your Korea Compliance Calendar.
We maintain a live compliance calendar for your product portfolio, manage all deadline-driven filings, and ensure that renewals, change notifications, and adverse event reporting obligations are met.
License Renewal Management
Tracking all 5-year renewal deadlines across your portfolio, preparing and submitting renewal applications to MFDS in advance of deadline, and managing MFDS renewal correspondence through to confirmation.
Change Notification Management
Monitoring your product change activity against MFDS change notification criteria, preparing and filing required change notifications, and maintaining a change history record for each product license.
Vigilance / Adverse Event Reporting
Receiving, triaging, and submitting adverse event reports to MFDS in accordance with Korean reporting timelines and Medical Devices Act obligations, and maintaining Korean vigilance records.
License Cancellation From a Missed Deadline Is Not a Recoverable Situation — It Is 18 Months of Lost Market Access.
90-Day Advance Deadline Notifications
We maintain a live compliance calendar for all products under retainer with 90-day advance notification of upcoming deadlines — so no renewal is ever a surprise and no filing is ever rushed.
Annual Compliance Status Report
We deliver an annual compliance status report for your full Korea portfolio confirming active license status, change history, and vigilance record — giving you documented audit evidence without internal resourcing.
Zero License Lapses for Manufacturers Under Korea License Maintenance.
5-Year Portfolio Renewal for a Small US Medical Device Company
Managed the simultaneous renewal of three Korea product licenses for a US manufacturer with no internal Korea RA team, completing all MFDS filings 60 days ahead of deadline with zero deficiency notices.
Change Notification Compliance for a European Device Portfolio
Monitored and filed nine MFDS change notifications across four product lines over a 24-month period for a European manufacturer, maintaining a complete and audit-ready change history for each license.
A Maintained, Current Korea License Portfolio.
For the cost of a modest annual retainer, Leanabl owns your compliance calendar and ensures that no deadline goes untracked and no required filing goes unsubmitted.
Speak with a Korea Compliance Manager TodayFrequently Asked Questions
Common questions answered.