What is a CH-Importer? Who needs it?

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 Swiss Customs - CH-Importer

CH-Importer: What is it and who needs it?

A CH-Importer is a natural or legal entity based in Switzerland responsible for importing medical devices into the country. While the CH-REP holds regulatory responsibility, the CH-Importer ensures that imported products comply with Swiss regulations and are properly placed on the market.

Why is a CH-Importer required? 

  • Ensuring Compliance: The CH-Importer verifies that products meet the requirements of the Medical Devices Ordinance (MedDO). 
  • Product Traceability: The CH-Importer documents imported medical devices and ensures they can be recalled in case of safety concerns. 
  • Collaboration with CH-REP and Authorities: The CH-Importer works closely with the CH-REP and relevant authorities to comply with all regulatory requirements.

Who needs a CH-Importer? 

  • Non-Swiss Manufacturers: These require a CH-Importer if they do not have a direct presence in Switzerland. 
  • Distributors and Retailers: If they import medical devices from abroad, they must either act as a CH-Importer themselves or designate an appropriate entity.

Conclusion 

A CH-Importer is essential for importing medical devices into Switzerland. They ensure compliance with Swiss regulations, facilitate product traceability, and act as a liaison between manufacturers, CH-REP, authorities, and the market. Without a CH-Importer, the legal distribution of medical devices in Switzerland is not possible.

Sources


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