Registration Maintenance
Overview
Maintaining an accurate and current DAPI registration is an ongoing post-market obligation. Manufacturers and CH REPs must promptly notify Swissmedic of significant changes and ensure all registration data remains accurate.
Ongoing Obligations
- Significant changes: Notify Swissmedic via DAPI when changes occur that affect intended purpose, safety/performance, or validity of conformity assessment — see Certificate Maintenance
- CH REP changes: Update DAPI promptly when CH REP mandate terminates or a new CH REP is appointed
- NB certificate renewals: Update DAPI when NB certificates are renewed
- Address changes: Update manufacturer and CH REP addresses promptly
- Device withdrawal: Update DAPI if a device is withdrawn from the Swiss market; retain technical documentation for the full retention period (10 or 15 years)
Annual Maintenance Fees
Annual maintenance fees may apply depending on device class — see Registration Fees and Timelines and the current Swissmedic fee schedule.
Official Sources
Disclaimer
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.