Serious adverse event reporting (SAER)

What is Serious adverse event reporting?

The MoCRA duty on the responsible person to report serious adverse events to the FDA within fifteen business days and to keep records of all adverse events for several years. A US contact number or address must appear on the label so consumers can report. Agree with your Korean supplier in advance how complaint information will flow back to the manufacturer.

At a glance

Category

Regulatory

Also known as

SAER · 중대한 유해사례 보고

Korean term

중대한 유해사례 보고

Last reviewed

July 23, 2026

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