Certificate Maintenance
Significant Changes Requiring DAPI Update
A change requires notification to Swissmedic where it may affect: intended purpose; safety and performance; validity of the existing conformity assessment (new/revised NB certificate). Examples: new NB certificate; reclassification; new indications; major design changes; change of manufacturer name/address; CH REP change; labelling changes.
Changes Not Requiring Re-notification
Minor changes with no clinical impact (e.g. colour changes, minor IFU text corrections not affecting use, addition of equivalent variants already covered by existing conformity documentation).
CH REP Change Process
- Old CH REP notifies Swissmedic in advance of mandate termination
- New CH REP appointed by manufacturer before old mandate ends
- New CH REP updates DAPI with new contact details
- If no new CH REP is appointed before termination, device must be withdrawn from market
NB Certificate Expiry
NB certificates are typically valid for 5 years. Initiate renewal at least 12 months before expiry. Update DAPI when renewed certificate is issued. Ensure no interruption in Swiss market supply during renewal.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.