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 ...

Responsibilities of the CH-REP The responsibilities of the CH-REP (Swiss Authorized Representative) are regulated in the Medical Devices Ordinance (MedDO). The CH-REP plays a central role in the regulatory process, particularly for companies based outside Switzerland that wish to distribute medical devices in the Swiss market. Representation of the Manufacturer The CH-REP acts as the legal representative of the manufacturer in Switzerland. It communicates with Swiss authorities, particularly with Swissmedic. It ensures compliance with Swiss medical device regulations. Documentation Obligations The CH-REP must keep all relevant documents (e.g., technical documentation, declaration of conformity) available. It ensures that the necessary evidence for the safety and performance requirements of the product is maintained. Upon request from authorities, these documents must be provided. A contract may be established to allow these documents to remain with the manufacturer and be provided upo...

  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 de...