USA – Switzerland eyes allowing FDA-approved medical devices onto its market

The Swiss parliament has asked the country’s Federal Council to adapt its laws to allow medical devices that have been vetted by non-European regulators, such as the US Food and Drug Administration (FDA) to be marketed in Switzerland. Currently, only EU-certified products are allowed on the country’s internal market based on a mutual recognition agreement between Switzerland and the EU.

On 28 November, the lower house of the Swiss Federal Assembly, also known as the National Council, approved a motion that mandates the Swiss Federal Council to develop regulations to allow medical devices approved by non-EU regulators into the country. The motion had already been approved by the upper house, also known as the Council of States, on 30 May.

The Federal Council now must adapt its national law and present an implementation proposal to allow non-EU regulated medical devices for use in Switzerland, which could open the door to allowing FDA-approved devices onto the market…