Label Requirements with CH-REP

posted


Swissmedic: Which label requirements with CH-REP for medical devices?

Swissmedic has published updated information regarding the labeling requirements for medical devices in Switzerland. These requirements apply to all stakeholders who wish to distribute or place medical devices on the Swiss market.

Regulatory Basis

The Medical Device Ordinance (MedDO) is closely linked to the Medical Device Regulation (MDR) (EU) 2017/745 and frequently references it. Therefore, compliance with MDR labeling requirements must be ensured. In addition, the specific labeling requirements of MedDO must be implemented.

CH-REP Labeling Requirements

The product or packaging must also display the CH-REP symbol, along with the name and address of the Swiss Authorized Representative (CH-REP).

  • The CH-REP symbol and associated data must not obscure any essential information on the packaging.

  • Detailed guidelines and reference documents are available on the Swissmedic website. Website and documents are available in DE, EN, FR, IT

  • This page also provides downloadable CH-REP symbols in various formats.

Placement of CH-REP Information

The placement of CH-REP details depends on the product type and applicable regulation:

  • MDR products: On the labeling.
  • MDD products (EU/EAA manufacturer or EC-REP): On the labeling, instructions for use, or an accompanying document.
  • AIMDD products (EU/EAA manufacturer or EC-REP): On the commercial packaging and instructions for use or an accompanying document.
  • MDD products (without EU/EAA manufacturer or EC-REP): On the labeling or instructions for use.
  • AIMDD products (without EU/EAA manufacturer or EC-REP): On the commercial packaging and instructions for use.

Stakeholders should verify which requirements apply to their products and whether transitional provisions are still in effect.

CH Importer Requirements

While Swiss importers (CH Importers) must also register with Swissmedic, similar to CH-REPs, their details may be displayed on the product or packaging.

  • It is sufficient if the CH Importer's details are provided on an accompanying document. 
    (See Swissmedic guidance document "Obligations of Economic Operators in Switzerland", MU600_00-016.)

Special Case: Liechtenstein Manufacturers

Manufacturers based in Liechtenstein do not require a Swiss Authorized Representative due to the customs treaty between Switzerland and Liechtenstein.

Sources


❓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 »