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Switzerland Importer 
For Medical Device & IVD Manufacturers 

Independent importer representation for meeting Swissmedic requirements

For decades, Switzerland seamlessly traded with its European Union neighbors under a Mutual Recognition Agreement (MRA). Unfortunately, Swiss and EU lawmakers could not agree on renewing the MRA after the adoption of the EU Medical Device Regulation (2017/745). As such, with regard to the regulation of medical devices, Switzerland is now much like the UK and manufacturers wanting to access the Swiss market must appoint an importer.  MedEnvoy can help you maintain access to the Swiss market.

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By working with MedEnvoy as your official importer in Switzerland, you avoid asking your distributor to take on this responsibility and therefore maintain more independence at a minimal cost. MedEnvoy already fulfills the role of importer for medical device companies exporting to the European Union and Great Britain so we have processes established to quickly and seamlessly verify your compliance with Swissmedic requirements. MedEnvoy can also act as your official Authorized Representative in Switzerland

MedEnvoy is an independent importer with offices in Zurich

Tasks we perform as your importer in Switzerland

✓ Verify Swiss declaration of conformity and technical documentation

✓ Verify that correct conformity assessment procedure has been performed

✓ Verify Labelling and accompanying information (IFU)

✓ Verify that Manufacturer has assigned UDI

✓ Verify that Manufacturer is identified

✓ Verify that storage and transportation requirements are fulfilled

✓ Maintain a register of complaints as required by law

✓ Inform manufacturer if device provides serious risk/is not in conformity

✓ Check to ensure that devices have been registered with Swissmedic

✓ Report to Swissmedic regarding serious incidents or risks

✓ Cooperate with Swissmedic regarding preventative /corrective action

✓ Check identification of devices within the supply chain

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The importance of keeping your importer separate from your Swiss distributor

Could you appoint your distributor as your importer in Switzerland? Technically, yes. But here's why that may not make sense. Your distributor is focused on marketing and selling your products, not checking to make sure your labeling, IFU or Unique Device Identification (UDI) are compliant with Swiss regulation. Plus, if you also sell in the European Union or Great Britain, it makes sense to have MedEnvoy as your independent importer representing you in all three European markets. 

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WE VERIFY

... that your devices have been correctly

registered with Swissmedic

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WE INSPECT

... that your UDI, product labeling and Instructions for Use are present

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WE NOTIFY

... you immediately if any product complaints are reported to us 

WE coordinate

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... with Swissmedic and distributors if there is a problem

Need more details? Contact us

Contact us for a free, no obligation proposal