Fines and Penalty Provisions

Administrative fines (과태료)

Administrative fines (not criminal) for less serious violations of the Medical Devices Act. Common triggers:

• Failure to report an adverse event within the required timeframe
• Failure to maintain required records
• Failure to register in KIMS / UDI-K by the required date
• Failure to notify MFDS of a change (변경신고)

Fine amounts vary by violation type and are specified in the Enforcement Decree.

Criminal penalties (벌칙)

More serious violations may result in criminal prosecution under the Medical Devices Act:

Offence	Maximum penalty
Manufacturing / importing without a licence	Imprisonment up to 5 years or fine up to ₩50 million
Selling without 품목허가 / 품목신고	Imprisonment up to 3 years or fine up to ₩30 million
False or fraudulent application	Imprisonment up to 5 years or fine up to ₩50 million
Obstructing a lawful MFDS inspection	Fine

Corporate liability

Both the individual employee responsible for the violation and the company may face penalties — the company can be fined even if only an individual is prosecuted.

Related pages

• Criminal liability for violations · Administrative actions