Swissdamed Database Launch: August 2024 Update

Swissmedic has recently announced the first module of the Swissdamed Medical Devices Database will go live on August 6th, 2024.

Note: If you are a customer, this update does not affect you as Swissmedic will automatically transfer MedEnvoy’s current registration into Swissdamed.

Actor Registration for the Swissdamed Database

Since the May 26th, 2021, Swiss economics operators, such as Manufacturers, Importers and Authorized Representatives, had to register with Swissmedic in order to obtain their unique registration number, CHRN (Swiss Single Registration Number). Such registration was initially conducted through the use of a PDF Application Form that was submitted via email to Swissmedic.

The aforementioned registration method will no longer be used from July 26th, 2024, onwards. Consequently, Swissmedic Mandates will also no longer be submitted via email after the aforementioned date.

Hence, in light of the above, from August 6th, 2024, onwards the Actor Module of Swissdamed will be available.

Therefore, Swiss Economic Operators will be required to solely register via the online contact form in Swissdamed. For Swiss Economic Operators that are already registered and have a CHRN, their information will be migrated by Swissmedic to the Swissdamed Database. Swissmedic will inform such operators via letter.

Consequently, such operators will not be required to register again, instead, they will check and confirm their data in the Swissdamed Database. Please note, as per the FAQ section in the Swissmedic website, pursuant to Art. 55(1) MedDO / Art. 48(1) IvDO, the registration requirement applies to Swiss- based manufacturers, Swiss Authorized Representatives of the foreign manufacturers, and Swiss-based Importers. Therefore, a non-Swiss manufacturer is not required to register as an actor in Switzerland, however, it must appoint a Swiss authorized representative (CH-REP).

Device Registration for the Swissdamed Database

The purpose of device registration in Swissdamed is to improve transparency, provide more in-depth information about the applicable devices on the Swiss market and, to demonstrate an overview of all the available ranges of devices on the market.

Considering this, Swissmedic has further announced that in 2025 they plan to make public the initial sections of the Swissdamed Database related to medical device, including in-vitro diagnostic devices, registrations. Therefore, on a voluntary basis, device registration will become available. However, no fixed timeline has yet been provided on when device registration will become compulsory; this is for now planned for a later date.

For more information, please visit the following Swissmedic webpage here.

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If you would like to discuss more about the Swissdamed database for Swiss-based medical device and IVD manufacturers, contact us so we can assist you. 

Learn how MedEnvoy can assist you:

• • Swiss Authorized Representative
  • Swiss Regulatory Importer
  • RA Consulting
  • QA Consulting