Registration Overview
Overview
Before placing a medical device on the Swiss market, the manufacturer or CH REP must notify or register the device with Swissmedic via DAPI. The requirement (notification vs full registration) depends on device class and MRA status.
Notification vs Registration by Class
| Device Class | Requirement | Timing |
|---|---|---|
| Class I (standard) | Notification | Within 30 days of first market placement |
| Class Im, Is, Ir | Notification with NB certificate details | Within 30 days |
| Class IIa | Full registration | Before first market placement |
| Class IIb | Full registration | Before first market placement |
| Class III | Full registration | Before first market placement |
| IVD General | Notification | Within 30 days |
| IVD List B, Self-test, List A | Full registration | Before market placement |
MRA Impact
- MRA operational: CE-marked devices generally don't require a separate full registration procedure; DAPI notification is still required
- MRA not fully operational: Full DAPI registration required for all devices regardless of CE status; EU NB certificate used as evidence
Always verify current MRA status before planning Swiss registration timelines — see MRA with EU.
Documents Typically Required (Class IIa+)
- Device description and identification (name, model, UDI-DI)
- Declaration of Conformity
- EU NB certificates (QMS + type/design examination where applicable)
- CH REP mandate and contact details
- Labelling samples demonstrating DE/FR/IT compliance
Official Sources
Disclaimer
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.