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JNM Global/Medical Device

Switzerland Swissmedic, Mandatory Device Registration with Swissmedic

JNM Global 제이엔엠글로벌 2025. 12. 30. 14:44

On December 23, 2025, Swissmedic announced that registration of medical devices and in vitro diagnostic medical devices (IVDs) in Switzerland (Swissdamed) will become mandatory from July 1, 2026, for any sales of these products within Switzerland. A transition period will apply until December 31, 2026.

 

Swissdamed is Switzerland’s regulatory compliance system, similar to the EU’s EUDAMED, serving as the national medical device registration database that tracks medical devices and IVDs sold in the Swiss market.

 

Since the Swissdamed product registration requirement is expected to take effect in Switzerland approximately one month after the mandatory implementation of EUDAMED registration in the EU (May 28, 2026), it is necessary to establish a registration plan for medical devices and IVDs during the transition plan for medical devices and IVDs during the transition period ending December 31, 2026.

 

Please refer to the link below.

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/frist-produktregistrierung-in-swissdamed.html

 

Deadline for Device Registration in swissdamed

The registration of devices, systems, and procedure packs will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026

www.swissmedic.ch


If you have any questions about medical devices,

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