Switzerland is not part of the European Union. Next to appoint a CH-REP, manufacturers outside of Switzerland also must appoint a CH-IMPORTER, who also needs to be registered at Swissmedic and get its CH-IMPORTER registration number.
Similar to the obligations as CH-REP, the CH-IMPORTER needs to ensure that the manufacturer fulfills the following requirements:
Verify Swiss declaration of conformity and technical documentation
Verify labeling, IFU, and that UDI has been approved
Verify that manufacturer and importer are identified
Verify that Swiss storage and transportation requirements are fulfilled
Maintain a register of complaints as required by Swiss law
Inform manufacturer if device provides serious risk or is not in conformity
Check to ensure that devices have been registered with Swissmedic
Report serious incidents or risks to Swissmedic
Cooperate with Swissmedic regarding preventive/corrective action
By working with QS Engineering as your Regulatory Importer in Switzerland, you avoid asking your distributor to take on this responsibility and therefore maintain more independence at a minimal cost while also alleviating a burden for your distributor.
Next to Regulatory Importer we also offer our Service as Physical Product Importer which is mainly interesting for manufacturers with different distributors in Switzerland. With this option you send your products always to our warehouse and we spread it from there to the designated Distributors. With this option you can safe transportation costs and you are more competitive in the market.
These services as CH-IMPORTER can be done as a stand-alone service or as an add on to our CH-REP mandate.
A Swissmedic leaflet about obligations of
Manufacturer, CH-REP and CH-IMPORTER
Your application form to get us your CH-IMPORTER in Switzerland
Check our options for Wharehousing, Administration and Accounting
Your Swiss Partner for Quality Management and Regulatory compliance!
