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
Legacy Device Registrations and Transitional Provisions
Devices that were lawfully placed on the Swiss market before the MedDO fully came into force may be subject to transitional provisions. Manufacturers should verify the specific deadline applicable to their devices for compliance with current MedDO requirements. Swissmedic's DAPI portal provides guidance on grandfathering arrangements and transition deadlines for devices registered under previous Swiss medical device regulations.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.
CH REP Requirement
Manufacturers not established in Switzerland must appoint a single Authorized Representative (CH REP) established in Switzerland. The CH REP is responsible for all communications with Swissmedic, registration updates, and compliance with Swiss requirements. Failure to maintain a CH REP mandate results in mandatory market withdrawal.