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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CH REP Authority and Liability
The CH REP acts on behalf of the manufacturer for all Swiss regulatory matters. The CH REP must ensure the manufacturer maintains compliance with Swiss regulations and must immediately notify Swissmedic of any safety issues, market withdrawals, or regulatory non-compliance. The CH REP does not assume liability for product safety but is accountable for regulatory correspondence and documentation accuracy.