At its meeting on April 30, 2025, the Swiss Federal Council adopted new guidelines intended to allow the approval of medical devices from non-European regulatory systems, such as the US Food and Drug Administration (FDA), in Switzerland. Until now, Switzerland has only accepted products approved under Swiss or EU law.
The conditions for approval include compliance with Swiss data protection rules, the introduction of quality management systems and a plan for post-market surveillance of the products. It should also be possible to request clinical evidence where needed.
To ensure these conditions are met, private bodies are to be commissioned to check FDA approvals against a simplified conformity assessment.
The Swiss government reported on this in a press release: Bundesrat legt Leitlinien für die Ausweitung der Versorgung mit Medizinprodukten fest