Medical devices: Switzerland soon aligned with the FDA?

The Swiss government is working on a simplified validation procedure for medical devices that have already been authorised by the US FDA – involving private bodies in the assessment.

During a session on 30 April 2025, the Federal Council has laid the groundwork for a wider supply of medical devices. The aim is to implement State Councillor Damian Müller’s motion (20.3211), which aims to open up the Swiss market to products subject to non-European regulatory regimes.

Towards recognition of FDA authorisations

At present, only devices certified as complying with Swiss or European standards can be marketed in Switzerland. The Müller motion proposes making this framework more flexible by authorising imports of products validated by other authorities, in particular the US Food and Drug Administration (FDA).
The Federal Council envisages entrusting private bodies with the task of verifying marketing conditions. These bodies will have to assess the conformity of devices already approved by the FDA using a simplified procedure, based in part on the controls carried out on the other side of the Atlantic.

Delegation to private bodies

‘The Federal Council wishes to delegate to private bodies the task of verifying the prerequisites for devices already approved in the United States by the FDA,’ states a press release. ‘This conformity assessment procedure will be simplified, since it will take account of the elements already examined by the FDA.’
A working group is currently examining how this motion will be implemented, in particular the differences between the FDA, Swiss and EU regulatory regimes. Initial recommendations include a number of prerequisites, such as compliance with Swiss data protection legislation and the introduction of a quality management system.

Next step

Responsibility for further work now lies with the Federal Department of Home Affairs (FDHA), in collaboration with the Federal Department of Economic Affairs, Education and Research (DEFR) and the Federal Department of Foreign Affairs (FDFA). Together, they will have to develop this approach further and define the precise contours of the future regulatory framework.

Source: Swiss Government | 📸 AI Generated Chat GPT