Forms & Application Links
Registration and Notification
| Resource | Link |
|---|---|
| DAPI registration portal | dapi.ch |
| Swissmedic — market access | swissmedic.ch/market-access |
Vigilance Reporting
| Resource | Link |
|---|---|
| Swissmedic eVigilance portal | swissmedic.ch/vigilance |
Clinical Investigations
| Resource | Link |
|---|---|
| ClinO-MD application (Swissmedic) | swissmedic.ch/clinical-trials |
| BASEC ethics submission | basec.ch |
Legislation (Fedlex)
| SR Number | Legislation | Link |
|---|---|---|
| SR 812.21 | TPA | fedlex.admin.ch |
| SR 812.213 | MedDO | fedlex.admin.ch |
| SR 812.219 | IVDO | fedlex.admin.ch |
| SR 810.305 | ClinO-MD | fedlex.admin.ch |
| SR 812.213.1 | Fees Ordinance | fedlex.admin.ch |
Reference
| Resource | Link |
|---|---|
| NANDO — EU Notified Bodies | ec.europa.eu/nando |
| MDCG guidance documents | European Commission |
| METAS (metrology) | metas.ch |
| MRA — Swiss SECO | seco.admin.ch |
| Fedlex — all Swiss legislation | fedlex.admin.ch |
Disclaimer
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.