Global Spotlight: Switzerland

Regulation

Authority: Swissmedic  

Key Leader: Vincenza Trivigno, Executive Director, Swissmedic

Points of Interest:

• Since the EU Mutual Recognition Agreement (MRA) lapsed, non-Swiss firms must appoint a Swiss authorized representative to market devices in the country.
• Mandatory device registration in the swissdamed database, distinct from the EU’s EUDAMED, begins July 1, with a transition period through December.
• Swiss and EU leaders signed agreements March 2 that would reinstate an MRA related to conformity assessment of products including devices 
• The Federal Council set guidelines last April to implement an alternative market pathway for FDA-authorized devices, but it likely won’t be active until at least 2028.

Reimbursement 

Authority: Federal Office of Public Health (FOPH)

Key Leader: Anne Lévy, Director-General, FOPH

Points of Interest:

• TARDOC, the new outpatient payment system, came into effect in January, introducing a combination of individual service tariffs and flat rates for defined procedures.
• The MiGeL (List of Aids and Equipment) details the maximum paid by health insurers for patient-facing devices but does not impose price controls on distributors.

More Resources

• Market Pathways has written previously about Switzerland’s moves to align with US FDA in the face of uncertainties in Europe. Ralph Nowak, a partner at Swiss family investment firm Winterberg Group provided an up-to-date account of the situation on his blog in September. 
• The entry on Switzerland in the consultancy MTRC’s Knowledge Zone provides a nice overview of the country’s medtech market access framework. 
• The health economics consultancy Stepval offers a deeper dive on the transition to the new TARDOC outpatients system. 
• An expert industry group convened by the trade association Swiss MedTech serves as a formal advisor to FOPH on maintaining the MiGeL. More details on that group’s efforts, as well as resource documents, can be found on the group’s webpage.