Responsibilities of the CH-REP

posted

Responsibilities of CH-REP

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 upon request.

Monitoring of Market Requirements

  • The CH-REP ensures compliance with market surveillance requirements in Switzerland.
  • It reports safety-related incidents (e.g., vigilance reports) to the authorities.

  • It is responsible for necessary product recalls or safety measures and acts as an intermediary between the authorities and the manufacturer.

Point of Contact for Swissmedic

  • The CH-REP serves as the primary contact person for Swissmedic.

  • It coordinates regulatory inquiries and inspections.
  • It ensures that the manufacturer meets all legal requirements.

Compliance with MedDO Requirements

  • The CH-REP ensures that MedDO requirements regarding conformity, clinical evaluation, product labeling, and instructions for use are met.

Responsibility for Recalls and Corrective Actions

  • In case of safety issues or defects, the CH-REP ensures that the manufacturer initiates appropriate corrective and recall actions.

  • Swiss authorities must be properly informed in such cases.

Sources

  • Medical Devices Act (MPG)


The responsibilities of the CH-REP extend throughout the entire lifecycle of a medical device in Switzerland—from placing it on the market to market surveillance and potential recalls—to ensure the safety and compliance of the product.


❓Are you a non-Swiss manufacturer or distributor of medical devices or in-vitro diagnostics looking to enter the Swiss market? Contact us today!

Location: Zug, Schweiz

Popular posts from this blog

Who/What is Swissmedic?

posted
Image
Swissmedic: The Swiss Agency  for Therapeutic Products Swissmedic is the Swiss regulatory and supervisory authority for therapeutic products, including medical devices and pharmaceuticals. It is an independent public institution under federal law and operates under the Federal Department of Home Affairs (EDI). Swissmedic plays a key role in the regulation, approval, market surveillance, and safety of therapeutic products in Switzerland. Tasks and Responsibilities of Swissmedic Approval and Registration: Swissmedic is responsible for approving pharmaceuticals and medical devices. It evaluates the safety, efficacy, and quality of products before they can be marketed in Switzerland. Market Surveillance: The agency continuously monitors the safety and quality of products through inspections and vigilance reports to identify potential risks at an early stage. Safety Management: Swissmedic assesses safety risks and implements necessary measures, including recalls or safety warni...
Read more »

What is a CH-Importer? Who needs it?

posted
Image
  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...
Read more »

Product Registration in Switzerland

posted
Image
Product Registration in Switzerland Swissmedic has published updated information regarding the product registration requirements on Swissdamed . These requirements apply to all stakeholders who wish to distribute or place medical devices on the Swiss market. Important Deadlines From July 1, 2026: All relevant products, systems, and treatment units must be registered with Swissmedic. By December 31, 2026: Full registration must be completed by the end of 2026 to ensure continued market access in Switzerland. Scope of Registration Requirement Currently, the registration requirement applies exclusively to Swiss manufacturers. Other economic operators, particularly Swiss importers, are not currently required to register products in Swissdamed. The planned change primarily affects the role of the Swiss Authorized Representative (CH-REP). Relevant Information Detailed information on registration requirements is available on the Swissmedic website under the "Medical Devices" section...
Read more »