Contacts / Links

General questions about products that fall within the scope of the medical devices regulations

We have compiled a list of frequently asked questions about medical devices in our FAQs:

• Questions frenquently asked by patients: Questions frequently asked by patients about medical devices 
• FAQ: Frequently Asked Questions on medical devices

General information and frequently asked questions (FAQ) on product groups without an intended medical purpose can be found on the following pages:
Product groups without an intended medical purpose

If you have any further questions please send us your request in writing. This will enable us to make the necessary clarifications internally.
questions.devices@swissmedic.ch

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.

Specific questions regarding transmission of information and data protection

• Encrypted e-mail communication via IncaMail
  The Medical Devices divisions at Swissmedic will in future be offering encrypted e-mail communication via IncaMail.
  This encrypted communication channel will be available on request. To use it, please get in touch with your contact person at Swissmedic.
  IncaMail will facilitate the secure transmission of messages in conformity with data protection regulations. Further information on IncaMail can be found here.

Case-specific questions on medical devices

• If you have a case-specific question, please consult the information provided on the respective web pages. Should you need additional help, please refer to the contact details given below.

Materiovigilance

Reporting incidents & FSCAs (vigilance)

To report serious incidents and field safety corrective actions
materiovigilance@swissmedic.ch

Clinical trials of medical devices

Clinical trials medical devices

Questions on a specific trial and submissions of SAE reports according to MDCG 2020-10/2

clinicaltrials.devices@swissmedic.ch

Free sales certificates

Issue of export certificates (Free Sales Certificates) for medical devices

Questions and answers FSC

Questions on free sales certificates:
fsc@swissmedic.ch

Notifications

Notification of medical devices

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

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.