Product Registration in Switzerland

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Medical Device Registration on Swissdamed

Product Registration in Switzerland


Swissmedic has published updated information regarding the product registration requirements on Swissdamed. These requirements apply to all stakeholders who wish to distribute or place medical devices on the Swiss market.

Important Deadlines

  • From July 1, 2026: All relevant products, systems, and treatment units must be registered with Swissmedic.
  • By December 31, 2026: Full registration must be completed by the end of 2026 to ensure continued market access in Switzerland.

Scope of Registration Requirement

Currently, the registration requirement applies exclusively to Swiss manufacturers. Other economic operators, particularly Swiss importers, are not currently required to register products in Swissdamed. The planned change primarily affects the role of the Swiss Authorized Representative (CH-REP).

Relevant Information

  • Detailed information on registration requirements is available on the Swissmedic website under the "Medical Devices" section in "Swissdamed" (see "Sources").
  • The information is accessible in four languages (German, French, Italian, and English) to ensure wide availability.

Recommended Procedure

  • Economic operators distributing medical devices in Switzerland should familiarize themselves with the requirements early.

  • Swiss manufacturers should complete the registration in time before the deadline to avoid delays or market access restrictions.

  • The economic actors should ensure in advance which data must be entered and in what format to prevent complications during the registration process.

  • On the Swissmedic website, under Medical Devices → Market Access → Medical Device Notification, various example lists can be downloaded in XLS format.

Sources



❓Are you a non-Swiss manufacturer or distributor of medical devices or in-vitro diagnostics looking to enter the Swiss market? Contact us today!


Location: Zug, Schweiz

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