Administrative Actions — Suspension, Revocation

MFDS administrative action toolkit

Action	Description	Trigger
Warning letter	Written warning requiring corrective action	Minor violation
Business improvement order	MFDS orders specific corrective actions	Moderate violation
Product sale suspension	MFDS orders suspension of sales for specific products	Safety risk or significant GMP failure
Licence suspension	Temporary suspension of manufacturer or importer licence	Serious violation
Licence cancellation	Permanent cancellation of licence	Very serious violation or fraud
품목허가 cancellation	Cancellation of product authorization	Device unsafe or application fraud
Import ban	Prohibition of importation for specific products or from specific manufacturers	Serious safety concern
Mandatory recall	MFDS orders a product recall	Imminent patient risk

Appeals

Manufacturers and importers may appeal MFDS administrative actions through:

1. Internal MFDS review (이의신청)
2. Administrative appeals tribunal (행정심판)
3. Administrative courts (행정소송)

Related pages

• MFDS inspection types and authority · Fines and penalty provisions