New FDA-Approval Process for Swiss Device Market Entry

Swiss Government Simplifying the FDA-Approval Process

On 30 April 2025, the Swiss Federal Council indicated to simplify the approval process for medical devices certified by the US Food and Drug Administration (FDA), allowing these products to be more easily introduced into the Swiss market. This change is in response to a parliamentary mandate to adapt legislation to accept products from non-European regulatory systems.

• Simplification of Approval Process: The Swiss government is working to implement a parliamentary order that will allow medical products certified by the FDA to be approved in Switzerland, which currently only accepts products with conformity declarations according to Swiss or EU law.  
• Safety Concerns and Regulations:  The government emphasizes the need for safety measures to be in place, including compliance with Swiss data protection laws and the establishment of a quality management system, in response to concerns raised by opponents regarding safety differences between European and US regulations. 
• Formation of Working Group:  To prepare for implementation, a working group has been established, comprising various Swiss health authorities. This working group identified differences between the regulatory systems. Based on this finding, the Federal Council intends to assign responsibility for reviewing the conditions for devices already authorized by the FDA in the US to private bodies. These bodies will review the relevant conditions under a simplified conformity assessment procedure, taking into account elements already performed by the FDA and to develop a monitoring plan for these products post-approval. 

This approach is currently under discussion and there is no available implementation timeline available at this time.

Additional information on the new Swiss FDA approval process can be found here.

For further information, contact us.

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