Swiss Compliance for
Importing Medical Devices

We offer consulting, training and templates
for the compliant import of medical devices into Switzerland.

Our ready-to-use templates give you the tools you need to fulfill the obligations.

With the Medical Device Ordinance (MedDO) and the Ordinance on In Vitro Diagnostics (IvDO), numerous requirements were introduced in 2021. Any company based in Switzerland that brings medical devices or IVDs from abroad onto the Swiss market is an importer. Without sufficient regulatory knowledge, compliance can be very cumbersome. It is therefore crucial to understand the role, tasks and obligations as a Swiss importer. You can find a detailed description in our blog.

We help you to grasp the requirements and accompany you in the implementation of the necessary quality management.

100+ customers trust Decomplix

We offer a simple and fast 4-step approach

  • Gap Analysis
    • You complete a case-specific questionnaire.
    • We assess your current compliance status and provide a gap analysis with actions needed.
  • Gap Closing
    • You get ready-to-use templates and examples for procedures and checklists necessary.
    • Together with you, we tailor them to the duties of the Swiss importer and your needs.
  • Training
    • We train and coach your concerned staff.
    • You understand how to use the procedures and templates in your daily work.
  • Maintenance
    • We continuously supports you in regulatory matters, like Swissmedic inspections.
    • You stay up to date on relevant regulatory changes.

Why Decomplix as your partner

  • Decomplix provides all you need for your Swiss medical device importer compliance from one source.

  • Decomplix operates under an ISO 13485 certified quality management system.

  • Decomplix’ customers benefit from expert consulting, training and ready-to-use templates simplify fulfilling your compliance.

  • Decomplix stands by as a coach in compliance matters and as the customer’s close contact to Swiss authorities.

  • 100+ medical device and in-vitro diagnostic companies of all shapes and sizes trust Decomplix — from startups to corporates, from Switzerland to all around the globe.

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Frequently asked questions about
importing medical devices to Switzerland

What are the duties of the Swiss medical device importer?

The duties of a Swiss importer under the MedDO/IvDO are relatively straightforward as they mirror those of an importer under Article 13 of the EU MDR/IVDR. The duties of a Swiss Importer can be clustered into the following sets of activities:

  • Verification of compliance
  • Suitable storage and transportation conditions
  • Device traceability
  • Registry of complaints, non-conforming products, recalls and withdrawals
  • Communication
  • Cooperation
  • Registration with Swissmedic (CHRN)

Even if not always mandatory, the Swiss importer should deploy its duties in a controlled manner, which calls for some quality management procedures.

More about the duties of Swiss Importers

 

Does the device labeling need to be updated with the Swiss importer?

The name and address of the Swiss Importer must appear on the device, on the packaging or in a document accompanying the device. Examples of documents accompanying the device: delivery note, warranty certificate, customs documents, invoice, a sticker on the packaging or instructions for use. We recommend the use of the term “CH IMPORTER” in German, French and Italian, as follows : “CH IMPORTEUR / IMPORTATEUR / IMPORTATORE”, and to avoid the use of the importer symbol of ISO 15223-1, which could be mistaken for EU importer.

More about labelling requirements

 

Is relabelling and repackaging by Swiss medical device importers allowed?

The requirements for entities that relabel and/or repackage devices under the MedDO/IvDO are the same as those under the EU MDR/IVDR, as governed by Article 16 of these Regulations.

If you are not familiar with these requirements, read more about relabelling and repackaging.

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