Why You Now Need a Swiss Importer
Switzerland was never a member of the EU, but in the interest of ensuring a smooth flow of goods across borders, it has traditionally signed Mutual Recognition Agreements (MRA) with the EU. When the EU Medical Device Regulation (MDR) took effect, an agreement to renew the medical device MRA was not reached. Without an MRA, Switzerland became a “third country” to the EU. As such medical device and IVD manufacturers without a registered office in Switzerland must now appoint a local Swiss Authorized Representative and Importer. With a registered office in Switzerland, our Partner MedEnvoy, offers these services to manufacturers.
Our Partner MedEnvoy, can act as your importer in the EU, UK and Switzerland!
Swiss Importer Responsibilities
As your Swiss importer, we will play an important role in your compliance with the Swiss Medical Devices Ordinance (MedDO). Shown below are some of our mandated legal obligations:
- Device labelled according to Swiss MedDO requirements, including listing importer
- Maintain a copy of the Declaration of Conformity and relevant certificates
- Verify that a tri-lingual IFU exists
- Verify UDIs have been assigned
- Inform manufacturer, distributors and CH-REP about complaints, field actions etc.
- Maintain a register to ensure that non-compliant products are not sold in Switzerland
- Inform Swissmedic if the importer believes the device does not comply with MedDO
- Check that storage and transportation conditions are suitable for the products.
- Cooperate with Swissmedic as required
How the Swiss Importer Process Works
Our Partner MedEnvoy, has developed a process that prevents duplication of efforts with your Swiss distributor(s) and CH-REP. We utilize technology to streamline the review and approval of your documentation and other SwissMedic obligations.
For maximum efficiency, we will work with you to develop contractual arrangements and QMS procedures, preventing redundant activities from being performed while ensuring your compliance with Swiss regulations.
Responsibilities that are specific to the Swiss Importer will be supported by procedures and work instructions that our Partner MedEnvoy will co-develop with you during the onboarding process. This will ensure speedy compliance checks and an uninterrupted flow of product shipments into Switzerland.
Have a subsidiary in Switzerland?
Manufacturers with an established legal entity in Switzerland can designate that entity as their Importer. Our Partner MedEnvoy, can provide “white label” back office services to your Swiss subsidiary to ensure all Swiss MedDO importer obligations are being met. Your subsidiary name goes on your labelling as the importer!
Benefits of Selecting an Independent Swiss Importer
- Your Importer must be identified on your product labeling. You maintain the flexibility to change distributors without reprinting all labeling.
- The importer must have permanent access to confidential technical documentation. We have no commercial interest in your devices but distributors certainly do.
- Having one company act as your single Swiss, EU and UK importer will streamline the management of contracts, labeling, shipping and overall compliance for all devices sold throughout Europe.
Swiss Importer Fee Structure
We charge the following fees for companies importing devices into Switzerland.
- Onboarding fee (one time)
- Annual importer service fee (based on the expected number of annual shipments)
NOTE: We can offer a multi-service discount if you also work with our Partner MedEnvoy as your UK and/or UK importer.