CH REP — Full Obligations Guide
Establishment Requirement (Art. 56)
The CH REP must be legally established in Switzerland with a registered office, branch, or subsidiary with substantive operations. Virtual offices and PO boxes do not qualify.
Mandate Agreement
Must be in writing, signed before devices are placed on the market. Should specify: devices covered; obligations of each party; liability allocation; incident reporting and FSCA management processes; data sharing; termination conditions.
Full Obligations (Art. 57)
| Obligation | Detail |
|---|---|
| DAPI registration | Register/notify all covered devices before or within 30 days of market placement |
| Vigilance reporting | Submit serious incident and FSCA reports to Swissmedic via eVigilance |
| FSCA coordination | Notify Swissmedic of FSCAs; coordinate FSN distribution to Swiss customers |
| DoC maintenance | Maintain copy of DoC; make available to Swissmedic on request |
| Implant card | For implantable devices: maintain and ensure implant card is provided with device |
| Cooperation | Cooperate with all Swissmedic market surveillance, inspection, and investigation activities |
| Complaint interface | Maintain processes for receiving and forwarding customer complaints to manufacturer |
Joint and Several Liability
The CH REP bears joint and several liability with the manufacturer for all MedDO/IVDO compliance obligations. This means Swissmedic can pursue enforcement action against either party independently. Private indemnification arrangements between the CH REP and manufacturer do not affect Swissmedic's enforcement authority or the CH REP's legal accountability to Swissmedic.
Terminating the Mandate
- CH REP notifies Swissmedic in advance of termination
- Manufacturer appoints new CH REP before old mandate ends, or withdraws device from market
- New CH REP updates DAPI with new contact details
- If no new CH REP is appointed before termination: device must be withdrawn from market
CH REP Public Register
Swissmedic maintains a publicly accessible CH REP register (name, address, contact details). Verify your CH REP is correctly listed.
Due Diligence When Selecting a CH REP
Consider: established Swiss track record; DAPI and eVigilance system experience; capacity for your device portfolio volume; contractual terms and liability framework; experience with your specific device types.
Official Sources
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.
During the transition period between old and new CH REP appointment, the manufacturer remains responsible for ensuring all incidents and complaints are properly reported to Swissmedic. Both the outgoing and incoming CH REP should coordinate to ensure no vigilance reporting gaps occur.