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Switzerland: Swissdamed actors’ module will become live in August 2024

The first module of the swissdamed medical devices database for the registration of companies and economic operators (ACT module) will become active on 6 August 20241.

Applications for the registration of, and changes to, the Swiss Single Registration Number (CHRN), as well as notifications for mandates, will continue to be accepted as PDF forms until 26 July 2024. After that date, these forms will no longer be considered. The ACT module of swissdamed will be available from 6 August 2024; from this date economic operators will need to register an application via the swissdamed online form.

The data for the almost 3,700 economic operators who have already registered with Swissmedic, and therefore possess a CHRN, will be migrated to swissdamed automatically. Registered operators will not need to register again; they will simply have to check their data once they have been migrated across.

In June 2024, a group of manufacturers and unique device identification (UDI) issuing agencies were invited to test the first upload options for medical devices in swissdamed. In 2025, Swissmedic plans to make available the first sections of swissdamed for the registration of certain devices on a voluntary basis. The compulsory registration of medical devices, including in vitro diagnostic medical devices, on the Swiss market is planned for a later date.

 

Reference

  1. https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/release-notes.html

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