Swissmedic to Conduct Random Inspections of Medical Device Importers in 2025

Swissmedic has announced plans to inspect selected medical device importers in Switzerland this year, emphasizing their crucial role in ensuring patient safety and supply chain integrity. Importers are responsible for verifying product conformity—including transitional provisions—before market placement, maintaining proper storage and transport conditions, and cooperating with authorities in cases of complaints, incidents, recalls, or other safety-related actions.

The initiative follows 2023 investigations revealing compliance gaps among some importers. Swissmedic views these inspections as essential to safeguarding public health. A randomly selected group of importers will be notified in writing before inspections take place.

Companies do not need to respond to the general information letter but will receive direct communication if chosen for inspection.

Swissmedic also reminded stakeholders that inspections may occur at any time, regardless of this planned initiative. Full details are available on the Swissmedic website.

12-09-2025