Adverse Event Reporting in Korea Is Not Optional — and the Clock Starts Immediately.
Your global PMS process does not satisfy MFDS vigilance requirements.
Foreign manufacturers frequently assume their global pharmacovigilance or MDR/MDV reporting procedures cover Korea. They do not. MFDS requires adverse event reports in Korean, submitted through MFDS-designated channels, within timelines as short as 15 days for serious events. Without a dedicated in-country vigilance function, most foreign manufacturers are non-compliant without knowing it.
End-to-End Korean Vigilance Management on a Subscription Basis.
Leanabl monitors your post-market signals, evaluates every adverse event complaint for MFDS reportability, and submits mandatory reports within the required Korean timelines. We act as your in-country PMS and vigilance function — permanently on standby.
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.
MFDS-Compliant Report Submission
We prepare and submit adverse event reports in Korean, through the correct MFDS reporting channel, within the mandatory 15-day (serious) or 30-day (non-serious) windows — with zero missed deadlines.
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.
What You Receive
Leanabl provides a complete, audit-ready vigilance record and regular structured reporting to your global quality team.
- 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
One Missed Report Can Suspend Your Entire Korean Product Portfolio.
MFDS enforcement is not lenient. A single serious adverse event unreported in Korea — even when correctly reported under EU MDR — can trigger a product sales suspension and damage your regulatory relationship with the agency for years. Leanabl's subscription model ensures a permanently active, Korea-qualified vigilance function from day one.
Activate Your MFDS Vigilance Coverage NowFrequently Asked Questions
Common questions about MFDS adverse event reporting obligations and how Leanabl's Vigilance subscription operates.