Swissmedic has published Version 3.1 of its “eMessage functions” information sheet, valid from 12 October 2026.
The document explains how the eMessage electronic government service can be used to submit and receive regulatory correspondence electronically for specific topics approved by Swissmedic. 1791873249760 1791873249760
Medical Device Topics Available Through eMessage
For medical devices, Swissmedic currently allows eMessage correspondence on several regulatory topics.
These include:
exemptions for non-conforming products;
certificates issued by Notified Bodies;
feedback on administrative proceedings related to marketing monitoring;
export certificates;
clinical trials. 1791873249760
This makes eMessage a key digital channel for certain interactions between Swissmedic and companies or individuals operating in the medical device sector.
Who Can Use eMessage?
The service can be used by both private individuals and companies.
Users must first open a personal account, which is used to submit information to Swissmedic and receive correspondence from the Agency. 1791873249760
Companies already using another Swissmedic eGov service may request authorisation for their existing account.
To activate eMessage, the company must accept the Special terms of use for eMessage by submitting a signed contract for the module. Once access has been approved, the company’s account administrator can manage additional user authorisations. 1791873249760
Electronic Mailbox and Notifications
The eMessage platform includes an electronic mailbox where correspondence from Swissmedic is stored.
Swissmedic correspondence is digitally signed, and users receive an email notification when new correspondence becomes available. 1791873249760
This provides a formal electronic channel for receiving regulatory communications.
Submitting a New Application
The “Delivery of a new application” function starts the electronic submission process.
After entering the necessary information, users can upload the associated documentation.
Depending on the type of correspondence, eMessage accepts:
PDF;
Excel;
ZIP files. 1791873249760
Responses to Swissmedic Must Use eMessage
One of the most important operational points in the updated information sheet concerns responses to Swissmedic correspondence.
Swissmedic states that answers and subsequent submissions must also be submitted through eMessage.
Submissions sent by email will not be accepted. 1791873249760
Users should select “Response to Swissmedic correspondence” as the delivery type when responding.
Swissmedic Reference Number Is Mandatory
When responding to Swissmedic or submitting additional documentation, users must provide the original Swissmedic reference number.
The document specifies that the relevant reference number, in the format 102xxxxxxx, must be entered under “Reference to original application number”. 1791873249760
This helps link additional submissions to the correct regulatory procedure.
Deliveries and Inbox Management
A company’s deliveries remain visible in the relevant eMessage list for 20 days. 1791873249760
Swissmedic correspondence is stored in the Inbox and can include:
acknowledgements of sending and receipt;
correspondence from Swissmedic;
official decisions. 1791873249760
However, Swissmedic explicitly warns that the Inbox should not be treated as an archive.
Users are expected to download and back up documents promptly. 1791873249760
Submission Acknowledgements
The portal automatically generates acknowledgements during the submission process.
These can be downloaded through the Dashboard or Inbox. 1791873249760
Three acknowledgement types are described:
Delivery confirmation — the portal has received the documents;
Acceptance of delivery — the portal has accepted the documents and processing is beginning;
Denial of acceptance — the portal cannot process the documents. 1791873249760
Acceptance of Delivery Is Critical
Swissmedic highlights the Acceptance of delivery as particularly important.
According to the information sheet, this acknowledgement is the only confirmation that Swissmedic has formally received the submission.
If the acceptance acknowledgement is missing, Swissmedic will not process the delivery further. 1791873249760
For regulatory teams, this makes verification of the acknowledgement a critical step after every submission.
Digital Signatures
Letters sent through the Swissmedic eGov Portal, including official decisions and acknowledgements, are provided with digital signatures.
Recipients can verify the validity of those signatures using standard PDF software. 1791873249760
For Class A certificates, Swissmedic also refers users to the Swiss Federal Administration’s Online Validator as an alternative signature-validation method. 1791873249760
Impact on Medical Device Companies
For medical device manufacturers, authorised representatives and other regulatory stakeholders interacting with Swissmedic, the updated information sheet reinforces the importance of disciplined electronic submission processes.
Organisations should ensure that internal procedures address:
correct eMessage account management;
use of the appropriate delivery type;
inclusion of the correct Swissmedic reference number;
timely download and archiving of correspondence;
monitoring of submission acknowledgements;
confirmation that an Acceptance of delivery has been received;
verification of digitally signed official communications.
Failure to monitor these steps could result in delayed or unprocessed submissions.
