Post-Market Surveillance Under MFDS: PMS, Vigilance, and License Maintenance

Three Regimes, One License

Korean post-market regulation is conventionally lumped under "MFDS PMS," but the practical work splits into three distinct regimes — each with its own forms, deadlines, and responsible parties. Manufacturers extending an FDA or EU post-market QMS into Korea often try to map all three onto a single procedure and miss reporting windows. The cleanest design uses three parallel procedures sharing common data sources.

Regime 1: PMS (Post-Market Surveillance)

MFDS requires manufacturers of Class II and higher devices to maintain a Post-Market Surveillance Plan as part of the technical file. The plan describes:

• The data sources monitored (complaints, returns, social media, hospital feedback channels)
• The frequency of trend analysis
• The thresholds that trigger investigation
• The reporting cadence to the KLH

PMS is not directly filed with MFDS on an ongoing basis. It is audited, both during KGMP surveillance audits and during MFDS post-market inspections. A weak PMS plan that has not produced any analyzed data in the last 12 months is the most common KGMP audit finding for foreign-manufactured devices.

The KLH is the data-aggregation point for Korean PMS. Complaints filed in Korea — by hospitals, patients, distributors — route through the KLH, who logs them and forwards them to the manufacturer per the PMS procedure. The KLH agreement should specify the SLA (typically within 5 business days for routine complaints, 24 hours for adverse events).

Regime 2: Vigilance (Adverse Event Reporting)

Vigilance is the reactive, event-driven regime. When an event occurs — a malfunction, an adverse outcome, a serious patient injury — MFDS requires reporting within specific timelines:

Event severity	Reporting deadline
Death	7 calendar days
Serious injury / hospitalization	15 calendar days
Malfunction (no harm but recurrence could cause harm)	30 calendar days
Trends not yet meeting threshold	Annual PMS report

Vigilance reports are filed through the MFDS Adverse Event Reporting System by the KLH. The manufacturer must supply the technical investigation and root cause analysis within the deadline window. A common failure: the manufacturer's RCA workflow assumes 30–60 days, but the Korean 7-day deadline for death cases requires preliminary RCA within 5 days. The investigation procedure must have a Korean-specific accelerated branch.

Regime 3: License Maintenance

The license-maintenance regime is the most underestimated. It includes:

• Annual quantity reports — total imports/sales volume by SKU, filed annually to MFDS through the KLH.
• Renewal notifications — most device licenses do not "expire" but the registration data (manufacturer address, KLH details, intended use phrasing) must be kept current. Any material change requires a notification.
• KGMP surveillance audits — annual third-party audits during the 3-year certificate period, with re-certification in year 3.
• Labeling change notifications — any change to the Korean IFU or label requires a notification, and changes that affect intended use require a full re-review.

A device with stable design but high commercial activity can generate 4–6 license-maintenance filings per year. Devices undergoing iterative software updates can generate 12+ filings per year — each of which requires KLH coordination and MFDS portal submission.

The Data Architecture That Actually Works

Foreign manufacturers who run Korean post-market well share a common data architecture:

Manufacturer global complaint database
   ▲
   │ daily/weekly sync
   │
KLH Korean complaint intake (Korean-language portal)
   │
   ├── PMS trending (quarterly analysis)
   ├── Vigilance (event-driven, 7-15-30 day clocks)
   └── License maintenance (annual quantity, change notifications)

The KLH is the funnel. The manufacturer's global database is the source of truth. Synchronization is daily-to-weekly depending on volume.

Manufacturers running each Korean complaint through the global ticketing system without KLH-side aggregation routinely miss vigilance deadlines because the global system has no Korean clock.

What Auditors Check

In KGMP surveillance audits and MFDS post-market inspections, the auditor's typical sample:

1. Three vigilance events from the last 12 months — pull the source complaint, the RCA, the MFDS submission, the date stamps. Verify the deadline was met.
2. One PMS trend analysis — verify the analysis was actually performed (not just scheduled) and that triggers/thresholds were applied.
3. One labeling change — verify the change went through the MFDS notification procedure, not just internal change control.
4. The annual quantity report — verify it was filed and that the numbers reconcile with import declarations.

If any of these four shows a procedural gap, the auditor expands the sample. The corrective action burden scales fast.

Three Operational Recommendations

Recommendation 1: Separate the procedures. Do not write one "Korean Post-Market" procedure. Write three: PMS, Vigilance, License Maintenance. The deadlines, responsible parties, and reporting channels are distinct.

Recommendation 2: Build the KLH dashboard. A monthly dashboard from the KLH showing complaint volume, vigilance events, PMS analysis status, and pending license-maintenance filings keeps the manufacturer ahead of audit findings.

Recommendation 3: Pre-translate the response templates. When a serious adverse event occurs, the 7-day clock starts immediately. Pre-translated response templates (Korean and English) cut the response time from days to hours.

What Goes Wrong Without a Plan

We routinely see manufacturers with otherwise-strong global PMS programs struggle in Korea because:

• Korean complaints sit untranslated in the KLH inbox for weeks before reaching the manufacturer's system.
• The vigilance clock is interpreted from the manufacturer's awareness date rather than the KLH's awareness date — MFDS uses the latter.
• License-maintenance filings are missed because the procedural owner sits in the manufacturer's RA team, which is not connected to the KLH's portal access.

Each of these is a procedure design problem, not a resource problem.

Where Leanabl Plugs In

The PMS, Vigilance, and Korea License Maintenance services together cover the three regimes. For manufacturers wanting all three managed under one operational program, Korea Post-Market Operations consolidates the work with KLH integration. Audit-readiness for these areas is handled through Korea Audit Readiness.