Submission of applications and notifications

The following items can be sent by email to clinicaltrials.devices@swissmedic.ch:

• Tabular listings of reportable serious adverse events and device deficiencies according to European reporting formats.
• Communications with no documents attached, e.g. for extension of deadlines, coordination needs, various questions.

In all other cases, you must follow the eGov submission procedures. In order for your submission to be handled correctly, standardised forms and a standardised folder structure are necessary and must always be used. Electronic submissions consist of three steps:

(1)   Prepare the standardised form and download the standardised folder structure
To prepare a submission, choose and fill in the correct form and download the standardised folder structure.

(2)   Generate an eDok
Copy the form, an accompanying letter if needed and every document into the correct folder. Your files should be in pdf or Excel format. Zip the whole structure (the standardised folders with all your files). This is called an “eDok”. One eDok includes one entire submission. In rare cases of errors due to size overload, you can split the submission (two eDoks for one submission).

(3)   Submit the eDok
Send eDoks for clinical trials of devices to Swissmedic via the Swissmedic Portal eMessage (www.swissmedic.ch/emessage-en). Swissmedic also runs a second portal, eSubmission, which cannot be used for devices.

In order to create an eGovernment account, you need an email-address and a mobile phone. Immediately after the registration step, you can submit to Swissmedic. A two-way identification procedure will be carried out for safety reasons each time you access the portal, with a code that is sent to your mobile phone. For a submission, answer the questions on the screen, select your eDok, select the “Upload” button and confirm. You will receive two automatic communications. The first one shows whether the 'submit' step was successful ('delivery confirmation'). Shortly afterwards, a second communication will show whether your files passed the technical validation ('acceptance of delivery' or 'denial of acceptance'). Confirmations and error messages will be stored in eMessage for you. Always check the messages you receive.

You should not store files in the portal. Instead, download correspondence of Swissmedic and store your submissions and the correspondence in the trial master file, so all authorised persons can access them during the clinical trial and the mandatory archiving period.

Further information is provided in the information sheet OS000_00_005e_MB

If you are unable to register or to submit, you can contact

for help.

Trouble shooting: The error message 'denial of acceptance' mostly occurs when the eDok format is not respected.