Question 1

Which adverse events must be mandatorily reported to MFDS?

Accepted Answer

Under Korean Medical Devices Act, serious adverse events — including death, serious injury, or cases requiring medical/surgical intervention — must be reported to MFDS within 15 days of the manufacturer becoming aware. Non-serious events where device malfunction could lead to serious injury must be reported within 30 days.

Question 2

What happens if we miss an MFDS reporting deadline?

Accepted Answer

Missing a mandatory adverse event reporting deadline is a violation of the Medical Devices Act. Sanctions range from administrative fines to product import suspension and, for repeated or serious violations, license cancellation. MFDS has significantly increased enforcement intensity against foreign manufacturers in recent years.

Question 3

Can we route all complaints from our global MDR inbox directly to Leanabl?

Accepted Answer

Yes. We work with your quality team to establish a complaint intake protocol where any report mentioning Korea — regardless of country of origin — is automatically routed to Leanabl for Korean reportability assessment. This eliminates the risk of a Korean event being lost in a global inbox.

Question 4

Does Leanabl manage the full CAPA process for adverse events?

Accepted Answer

We manage the Korean regulatory dimension of CAPA — meaning we coordinate with MFDS on required follow-up reporting and ensure your CAPA documentation meets Korean format requirements. The root cause investigation and corrective actions themselves remain with your global quality organization.

Question 5

What happens if an event load or follow-up requirement exceeds our retained scope?

Accepted Answer

The annual retainer is scoped to an expected event volume and a defined set of activities — routine signal monitoring, reportability assessment, MFDS submission, and standard follow-up. Out-of-scope work — major complex follow-up reports, event-volume spikes, multi-jurisdiction CAPA coordination, or MFDS hearings — is billed hourly and requires prior written approval before we exceed the included scope. You see the estimated effort, the rationale, and the cap before any extra work begins; no surprise charges.

Adverse Event Reporting

Your global PMS process does not satisfy MFDS vigilance requirements.

Continuous Signal Monitoring

MFDS-Compliant Report Submission

Follow-Up and CAPA Coordination

What You Receive

Frequently Asked Questions

One Missed Report Can Suspend Your Entire Korean Product Portfolio.