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 ...

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...

Swissmedic: Market Surveillance of Medical Devices Swissmedic, the Swiss regulatory and supervisory authority for therapeutic products, conducts comprehensive examinations for market surveillance and compliance with regulatory requirements for medical devices. These inspections ensure that medical devices comply with legal requirements and do not pose a risk to patients or users. Types of Inspections by Swissmedic Approval Review (Conformity Assessment) Before being placed on the market, a medical device must undergo a conformity assessment to ensure compliance with the Medical Devices Ordinance (MedDO, SR 812.213) and the Therapeutic Products Act (HMG). The manufacturer or the CH-REP is responsible for providing all required documentation, including technical documentation and the declaration of conformity. Swissmedic may verify the conformity assessment by the manufacturer or a notified body and, on a case-by-case basis, request additional evidence regarding the safety and performan...

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 ...

  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...

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...