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CH-IMPORTER
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.
