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 ...

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...

  CH-REP: What Is It and Who Needs It? What Is a CH-REP? A CH-REP (Swiss Authorized Representative) is a natural or legal person based in Switzerland who acts as a representative for companies wishing to distribute medical devices on the Swiss market. The abbreviation "CH-REP" stands for "Swiss Responsible Person" and refers to a key role in ensuring compliance with regulatory requirements under the Swiss Medical Devices Ordinance (MedDO). Why Is a CH-REP Required? According to the Medical Devices Ordinance (MedDO, SR 812.213), manufacturers without a registered place of business in Switzerland must appoint a CH-REP. This representative assumes essential responsibilities to ensure the conformity of products with Swiss regulations: Legal Responsibility: The CH-REP serves as the official representative of the manufacturer and assumes regulatory responsibility towards Swiss authorities. Regulatory Compliance: Ensures that all requirements of the Medical Devices Act are...

Swiss Authorized Representative for Medical Devices (CH-REP) The Swiss Authorized Representative (CH-REP) is a legally required entity for manufacturers outside Switzerland who wish to market their medical devices in the Swiss market. The CH-REP role was established with the introduction of the revised Medical Devices Act (MPG) and the Medical Devices Ordinance (MedDO) to align Swiss legislation with the EU Regulations 2017/745 (MDR) and 2017/746 (IVDR). Timeline of CH-REP and CH-Importer Introduction May 26, 2021: The revised Medical Devices Act (MPG) and MedDO come into force. December 31, 2021: The Mutual Recognition Agreement (MRA) between Switzerland and the EU for medical devices expires. Why is a CH-REP Necessary? With the expiration of the MRA, the previous simplifications for the import and distribution of medical devices from the EU to Switzerland ceased. Manufacturers outside Switzerland who wish to continue offering their products in the Swiss market are now required to...