Responsibilities of the CH-Importer

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Responsibilities of CH-Importer

Responsibilities of the CH-Importer

The CH-Importer plays a key role in ensuring the safe and compliant importation of medical devices into Switzerland. According to the Medical Devices Ordinance (MedDO, SR 812.213), the CH-Importer is responsible for ensuring that imported products comply with Swiss regulations and are correctly placed on the market.

Key Responsibilities of the CH-Importer

  • Compliance Verification: The CH-Importer ensures that imported products meet the requirements of the MedDO and possess the necessary certifications as well as a valid CE marking.

  • Labeling Requirements: The CH-Importer verifies that products are correctly labeled and that instructions for use are available in an official language of Switzerland.
  • Documentation and Traceability: The CH-Importer maintains detailed records of imported products to ensure full traceability. These records must be readily available for inspections and requests from authorities.

  • Reporting Obligations: The CH-Importer informs Swissmedic, the manufacturer, and the CH-REP of safety issues, unexpected incidents, or product recalls to facilitate a swift response to potential risks.
  • Collaboration with Authorities: The CH-Importer ensures that all relevant documents are available for Swissmedic or other competent authorities and supports inspections or regulatory reviews.

  • Coordination with the CH-REP and Manufacturer: The CH-Importer works closely with the CH-REP and the manufacturer to ensure that all regulatory requirements are met throughout the entire supply chain.

Conclusion

The CH-Importer serves as an essential link between the manufacturer, the CH-REP, and Swiss authorities. Their responsibilities range from product verification and labeling to documentation and market surveillance. By ensuring compliance with regulatory requirements, the CH-Importer contributes significantly to the safety and quality of medical devices in Switzerland.

Sources


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