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, corporate and individual liability)
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