Swissmedic is in the process of developing a new database for registering economic operators and medical devices.
Due to the continuing aim of equivalence between regulation in Switzerland and the EU, the medical devices database will be similar to EUDAMED. The new medical devices database will include registration of economic operators and medical devices. It will be possible to register medical devices by mass upload.
Economic operators who are already registered with Swissmedic or who register before the introduction of the medical devices database (unique identification number, CHRN) will not have to re-register (data migration).
Swissmedic will communicate a timetable for the introduction of the medical devices database by the middle of this year.
All relevant specifications for stakeholders will be published on the Agency website as soon as they are available.
For more information, please visit Swissmedic website.
Meditrial is supporting medical device and IVD companies with regulatory compliance and market entry since 2008.
With offices in Europe (including Switzerland) and the US, Meditrial offers a wide range of market access services, including regulatory compliance, consulting, device registration, and in-country representation. Don’t hesitate to contact us!
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