For Medical Device & IVD Manufacturers
Independent Representation for Meeting Swissmedic Requirements from Europe's #1 Regulatory Importer!
Trusted by 550+ Medical Device & IVD Manufacturers Worldwide
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Switzerland is not an EU member but has traditional traded with their neighbors under a Mutual Recognition Agreement (MRA). The MRA was not renewed after the adoption of the EU Medical Device Regulation (2017/745) so now Switzerland is a “third country” much like the UK. Manufacturers must appoint a Swiss regulatory importer and Authorized Representative (CH-REP).
By working with MedEnvoy 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. MedEnvoy already fulfills the role of EU importer and UK importer for 200+ medical device companies exporting to the European Union and United Kingdom so we have processes established to verify your compliance quickly and seamlessly with Swissmedic requirements. We can also act as your official Authorized Representative (CH-REP) in Switzerland.
Tasks we perform as your Swissmedic compliance importer
Regardless of whether you are selling legacy devices holding existing CE certificates under the European MDD/IVDD, you’ll still need to register in Switzerland and appoint a Swiss-based importer. We don’t handle your products or slow down shipments but we do....
✓ Verify Swiss declaration of conformity and technical documentation
✓ Verify labelling, IFU and that UDI has been assigned
✓ 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/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 preventative /corrective action
MedEnvoy is ISO 13485:2016 certified.
Maintain Flexibility by Keeping Your Swiss Importer Separate from Your Distributor
Can a distributor act as your importer in Switzerland? Yes, but there are many reasons to avoid that option. Your distributor is focused on selling your products, not checking your compliance with the specific requirements of the Swiss medical device regulation (MedDO). Plus, keep in mind that the name and contact information of your Swiss Importer must be prominently displayed, potentially creating conflicts with other distributors. 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. Learn more about how the process works.
... that your devices have been registered with Swissmedic
... that your UDI, product labeling and Instructions for Use are present
... you immediately if any product complaints are reported to us
...with Swissmedic and distributors if there is a problem