General questions about medical devices
Wherever, possible we answer straightforward telephone questions immediately. If your question is more extensive and will need a more detailed response, please submit it in writing so that we can make the necessary enquiries within the Agency.
Note
We draw your attention to the fact that responding to questions is normally subject to a fee of CHF 200.00 per hour. No charge is made for information that requires less than 0.5 hrs. of work.
Information is provided free of charge for the following groups:
- Patients and consumers or their associations
- Representatives of public authorities, political bodies and organizations
- Media: information for journalists.
Case-specific questions on medical devices
- If you have a question about a specific case, please contact one of the following
Materiovigilance
To report serious incidents, risks or safety measures
materiovigilance@swissmedic.ch
Clinical trials of medical devices
Questions on a specific trial and submissions of up to 20 pages (e.g. SAE reports or Annual Safety Report)
clinicaltrials.devices@swissmedic.ch
Free sales certificates
To order or ask questions about free sales certificates
fsc@swissmedic.ch
Notifications (in acc. with Art. 6 MedDO)
Notifications, changes
notifications.devices@swissmedic.ch
Market control
Other reports
medical.devices@swissmedic.ch
Speakers activities
Queries regarding provision of speakers by Swissmedic
Networking@swissmedic.ch
Address
Swissmedic
Division medical devices
Hallerstrasse 7
CH-3012 Berne
Switzerland
Recall list subscriptions
Please note that since the design of our web page was changed, you can no longer subscribe to the medical devices recall list yourself. If you would like to continue to receive this information at regular intervals, please register by sending your e-mail address to medical.devices@swissmedic.ch.
Important: Size limitation of e-mail attachments
Please be aware that our e-mail system does have a capacity limitation of 10 MB. If your documentation is above that limit, please use the Filetransfer Service (FTS). To be able to use this service, please contact one of the addresses given above, depending on the issue concerned.
You will then receive an invitation e-mail containing your user name and password. The link in the e-mail will take you to the FTS web interface where you can enter the user name and password that you received. Please then change your password and proceed with «Change Password».
You are now registered as an external user. The account is valid for 90 days and you can send files up to 10 GB in size.