Korea Adverse Event Reporting Update — Quarterly Product Problems Versus Expedited Reports

Key takeaway — Korea's reporting amendment is in force. Determine the reporting category before calculating the deadline. Quarterly submission for eligible product problems does not replace expedited reporting for serious patient outcomes.

What changed after the consultation?

The proposal announced as Notice 2026-402 on 13 August was finalized as MFDS Notification 2026-67, effective 22 September 2026. Article 5(1)3 separates other adverse events, foreign governmental measures, and qualifying product problems into different reporting schedules.

This guide deals with that reporting decision and the transition of open cases. The broader duties after registration are covered in our post-approval obligations guide. Adverse event reporting and a separately designated post-market study are different procedures.

Which reporting clock applies?

Start with the patient outcome and record the provision used. The table helps classify a report; it does not decide whether recall or immediate protective action is needed.

Known facts	Reporting rule
Death or life-threatening outcome	Enforcement Rule, Article 51: initial report within 7 days; detailed follow-up within 8 days of the initial report
Hospitalization or its extension, irreversible or serious disability or functional impairment, congenital anomaly	Article 51: within 15 days
Adverse event outside Article 51(1)	Notification, Article 5(1)3(a): within 30 days
Foreign government announcement or measure	Article 5(1)3(b): within 30 days; check the separate omission provision where a recall plan has been reported
Defect or malfunction with no patient health or clinical impact at the time, but potential undesirable effects	Article 5(1)3(c): within one month after the relevant quarter ends

Keep the date the company learned of the facts separate from the manufacturer's investigation completion date. A late final investigation report does not by itself move the initial awareness date.

Is an absence of injury enough to classify the case?

Distinguish a cosmetic return from an incorrect measurement or interruption during treatment. A power failure discovered in storage raises different questions from the same failure during patient use. If patient impact remains unknown, record it as an open question with an owner, not as a confirmed absence of impact.

For example, discovering a defect before patient use may establish that no patient was affected, but the team still needs to assess what the defect could cause. This is an operational example, not a blanket regulatory classification of that failure. Uncertain seriousness should have a prompt escalation route to the responsible quality staff.

How should open cases cross the effective date?

The addenda apply the amendment to cases learned of after 22 September and to earlier cases whose old reporting deadline had not expired. Reconcile the open-case list when changing the procedure:

1. Preserve the initial awareness date, previous deadline, and reports already submitted.
2. Identify whether the old deadline remained open on the effective date.
3. Reassess patient impact and the applicable reporting category.
4. Record approval of the resulting deadline without overwriting the original history.

Moving every unresolved case to the next quarter-end conceals missed deadlines. Using only the month of occurrence can also miss the distinction between occurrence and awareness.

What records should connect the complaint to the report?

Link the official reporting form to the internal complaint identifier. A useful working register includes the model, registration number, lot or serial number, domestic or overseas location, occurrence and awareness dates, patient outcome, manufacturer investigation status, reporting category, deadline, submission history, and follow-up actions. This is a practical register design, not a substitute for the prescribed form.

Check product identity against the item and model data described in our integrated information system guide. Limit personal information to what reporting and investigation require. Article 51(1) requires the relevant adverse-effect reporting materials to be retained for two years; a submission receipt alone does not preserve the supporting record.

What should the team change this week?

Add patient-impact questions to intake, introduce a distinct quarterly category in the deadline register, and agree with the overseas manufacturer how initial facts will be shared before the investigation closes. Training should explicitly correct the assumption that all reporting has become quarterly.

Collection, evaluation and urgent escalation continue throughout the quarter. Only submission timing changes for the qualifying category. Share representative complaints and the current procedure through our free pre-review so we can identify the decision points and documents that need revision.

Official sources checked 28 September 2026: MFDS Notification 2026-67 and amendment documents; Safety Information Management Regulation, Articles 2, 4 and 5 and addenda, effective 22 September 2026; Medical Devices Act Enforcement Rule, Article 51, Ordinance 2127, effective 1 July 2026. Operational recommendations in this article are distinguished from the statutory deadlines.