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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:

OffenceMaximum penalty
Manufacturing / importing without a licenceImprisonment up to 5 years or fine up to ₩50 million
Selling without 품목허가 / 품목신고Imprisonment up to 3 years or fine up to ₩30 million
False or fraudulent applicationImprisonment up to 5 years or fine up to ₩50 million
Obstructing a lawful MFDS inspectionFine

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.

Fine amounts for common violations: Failure to report adverse events within 15 days may incur fines up to ₩5 million. Failure to maintain required records or register in KIMS/UDI-K may result in fines up to ₩3 million. Failure to notify MFDS of product changes may incur fines up to ₩2 million. Refer to the Medical Devices Act Enforcement Decree Article 85 for the complete schedule of administrative fines.