Continuous Signal Monitoring
We maintain an active watch on adverse event complaints, field safety signals, and post-market feedback routed through your organization, capturing every event that may trigger an MFDS reporting obligation.
Adverse Event Reporting
Adverse Event Reporting in Korea Is Not Optional — and the Clock Starts Immediately.
Your global PMS process does not satisfy MFDS vigilance requirements.
MFDS-Compliant Report Submission
We prepare and submit adverse event reports in Korean through the correct MFDS reporting channel, tracking the mandatory 15-day and 30-day reporting windows.
Follow-Up and CAPA Coordination
Where MFDS requires follow-up reports or corrective action documentation, we coordinate with your global quality team to prepare the required Korean-format response and close the loop with the agency.
Service specification
Korea Adverse Event Reporting
Leanabl provides a complete, audit-ready vigilance record and regular structured reporting to your global quality team.
Request assessmentGlobal pharmacovigilance procedures do not cover Korea. MFDS requires adverse event reports in Korean through designated channels, within 15 days for serious events.
Adverse Event Log with MFDS reportability assessment for every complaint
MFDS Adverse Event Report submissions with official receipt confirmations
CAPA Coordination Memos linking field events to corrective actions
Korean PMS Plan reviewed and aligned with MFDS post-market requirements
Annual Vigilance Summary Report for your quality management system records
Frequently Asked Questions
Common questions about MFDS adverse event reporting obligations and how Leanabl's Vigilance subscription operates.