Criminal Liability for Violations

The Medical Devices Act includes criminal penalty provisions for the most serious violations.

Prosecutable offences

Offence	Penalty
Supplying an unapproved device (without 품목허가 / 품목신고)	Up to 3 years imprisonment or ₩30M fine
Manufacturing without a manufacturer licence	Up to 5 years imprisonment or ₩50M fine
Fraud in a regulatory application	Up to 5 years imprisonment or ₩50M fine
Failing to comply with a mandatory recall order	Up to 3 years imprisonment or ₩30M fine
Causing death or serious injury through negligent regulatory violation	Aggravated criminal penalty

Dual liability (양벌규정)

Under the 양벌규정 (dual liability) provision:

• Both the individual who committed the offence and the company may be prosecuted and penalised
• Companies cannot shield themselves from criminal liability by pointing to an individual employee's conduct

Related pages

• Fines and penalty provisions · Administrative actions