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Recognition of FDA-approved medical devices in Switzerland

Business environment

29 November 2022

The Swiss Government will be amending the legislation enabling Switzerland to accept medical devices with FDA approval for the welfare of its own population.

Until today, patients can only be treated in Switzerland with medical devices that have been certified by the EU.

The Swiss authorities have taken a necessary decision for the sustainable supply of quality-controlled medical devices to the Swiss population. The Government is instructed to adapt the national law in such a way that, in addition to medical devices with an EU certificate (CE mark), medical devices with a U.S. Food & Drug Administration (FDA) approval are also recognized in Switzerland.

Greater flexibility in the procurement of medical devices for the supply of the Swiss population

Because of its size and resources, Switzerland cannot produce all the medical devices it needs, nor can it assess their conformity for market authorization. It is dependent on foreign countries for both the evaluation and procurement of products for domestic supply.

As the EU is Switzerland’s main trading partner, Switzerland currently only accepts medical devices that are CE or MD marked in accordance with the EU regulatory system.

“It is now important that the motion is implemented quickly and pragmatically. There is no need for a complex implementation scheme, as is sometimes claimed,” explained Sandra Rickenbacher, member of Swiss Medtech’s Management Board.

According to Swiss Medtech, the examples of Australia and Israel show that a more streamlined system is also possible. In these countries, an efficient procedure for the recognition of FDA approvals in parallel with that of CE-approved medical devices has proved successful.