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:
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.
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.
Reporting incidents & FSCAs (vigilance)
To report serious incidents, risks or safety measures
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
Notification of medical devices
Queries regarding provision of speakers by Swissmedic
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 firstname.lastname@example.org.
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.