Fines and Penalty Provisions
Administrative fines (๊ณผํ๋ฃ)โ
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 (๋ณ๊ฒฝ์ ๊ณ )
Fine amounts vary by violation type and are specified in the Enforcement Decree.
Criminal penalties (๋ฒ์น)โ
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 โฉ50 million |
| Selling without ํ๋ชฉํ๊ฐ / ํ๋ชฉ์ ๊ณ | Imprisonment up to 3 years or fine up to โฉ30 million |
| False or fraudulent application | Imprisonment up to 5 years or fine up to โฉ50 million |
| Obstructing a lawful MFDS inspection | Fine |
Corporate liabilityโ
Both the individual employee responsible for the violation and the company may face penalties โ the company can be fined even if only an individual is prosecuted.
Related pagesโ
Fine amounts for common violations: Failure to report adverse events within 15 days may incur fines up to โฉ5 million. Failure to maintain required records or register in KIMS/UDI-K may result in fines up to โฉ3 million. Failure to notify MFDS of product changes may incur fines up to โฉ2 million. Refer to the Medical Devices Act Enforcement Decree Article 85 for the complete schedule of administrative fines.