CH REP Registration Duties
Pre-Registration Checks
Before submitting a DAPI registration, the CH REP must verify: conformity assessment is complete and a valid DoC has been issued; device labelling complies with Swiss requirements (DE/FR/IT); NB certificates are valid and cover the specific devices; the CH REP mandate is in place and covers the devices to be registered.
DAPI Submission
The CH REP submits on behalf of the manufacturer, including: device identification data; manufacturer details; CH REP contact details; DoC; NB certificates; labelling samples. The CH REP is the registered Swissmedic contact for all communications regarding the device.
Post-Registration
After registration: promptly update DAPI when manufacturer details, device details, or CH REP contact information changes; notify Swissmedic of significant changes; ensure registration is renewed and fees paid on time; maintain copies of all registration documents for the required retention period.
Official Sources
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