Authorisation applications and notifications relating to clinical trials with medical devices should be submitted to Swissmedic electronically via the eGovernment Service eMessage.
Submission of authorisation applications and notifications relating to clinical trials with medical devices
Electronic eDok submission
eDok is a submission format for authorisation applications and notifications relating to clinical trials with medical devices. The eDok application is submitted via the eGov Service eMessage. The upload completely replaces the submission of paper documents.
Swissmedic runs a second portal, eSubmission, which should not be used for medical devices.
For initial registration, you need an email-address and a mobile phone. Immediately after the registration step, you can submit to Swissmedic.
Please be aware that you can only see correspondence made under your ID, not messages concerning the same clinical trial sent to other users that have used a different ID. Your submissions and the messages of Swissmedic should normally be stored in the Trial Master File, so that all authorised persons can access them during the clinical trial and the subsequent archiving period.
If you are unable to register or to submit an electronic submission, you can contact
for help.
| Subject | Requirement |
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| eDok structure |
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| File formats |
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| File size |
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| File names |
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| Preparation for submission (upload eMessage) |
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Login/self-registration eMessage
www.swissmedic.ch/emessage-en
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Instructions
Login/self-registration eMessage
www.swissmedic.ch/emessage-en
Last modification 01.06.2018