Swissmedic Enforcement Powers
Overview
Swissmedic has broad enforcement powers under TPA Chapter 8 to address non-compliant devices on the Swiss market, ranging from information requests to criminal prosecution.
Administrative Measures
| Power | Basis |
|---|---|
| Information requests (technical docs, DoC, NB certs, complaint records) | TPA / MedDO Art. 76ff |
| Inspection orders (announced or unannounced) | TPA / MedDO Art. 81 |
| Recall orders (where manufacturer fails to act) | TPA / MedDO Art. 83 |
| Prohibition on supply of non-compliant devices | TPA / MedDO Art. 84 |
| Seizure and confiscation of non-compliant devices | TPA Art. 66 |
| Import controls / border seizure | TPA Art. 67 |
| Withdrawal of DAPI registration | MedDO / TPA |
Refusal to cooperate with information requests is itself a regulatory offence under the TPA.
Criminal Penalties
Serious TPA violations can result in criminal prosecution under TPA Art. 86–91:
- Fines up to CHF 200,000 for negligent violations
- Fines up to CHF 500,000 or imprisonment for intentional violations
- Criminal liability extends to individuals (directors, QA managers) as well as legal entities
Official Sources
Disclaimer
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.