Voluntary vs MFDS-Ordered Recalls

Voluntary recalls

Initiated by the manufacturer or importer based on their own quality investigation.

Steps:

1. Identify the safety issue and affected products (batch, lot, serial, UDI)
2. Notify MFDS via the adverse event/recall reporting portal before or at initiation
3. Execute the recall — notify supply chain, healthcare facilities, and (for high-risk devices) patients
4. Submit a recall completion report to MFDS

MFDS-ordered recalls

MFDS may order a mandatory recall when:

• The manufacturer/importer has not voluntarily recalled a device with a known safety risk
• MFDS determines an immediate public health risk exists

Failure to comply is a serious regulatory violation — potential for criminal penalties.

Related pages

• When a recall or FSCA is required · MFDS-initiated corrective actions

Notification timeline: Manufacturers must notify MFDS of a voluntary recall before or at the time of initiation. Notification should be submitted via the adverse event/recall reporting portal or eSubmission system and must include the product identification (품목허가 number, batch/lot/serial numbers, UDI if applicable), reason for recall, and expected completion date.