CHREP.me Blog – CH-REP and CH-Importer

Every medical device or IVD from a foreign manufacturer that is placed on the Swiss market must name its Swiss Authorised Representative (CH-REP). Swissmedic has published a dedicated CH-REP symbol for this, and its information sheet on economic operators sets out exactly where the CH-REP details have to appear. This article summarises the current rules. What is the CH-REP symbol? The CH-REP symbol is the official Swissmedic pictogram that identifies the authorised representative in Switzerland. You can download it free of charge from the Swissmedic CH-REP page in AI, EPS, JPG and PNG format. The official CH-REP symbol. Source: Swissmedic Its official meaning is "Indicates the authorised representative in Switzerland". Swissmedic accepts the symbol without explanatory text on the label, provided the product documentation explains it. Instead of the symbol, you may also use a text label: "CH authorised representative", "CH-REP" or "Authorised rep...

Product Registration in Switzerland Updated on 28 October 2026 to reflect the current Swissmedic requirements. Since 1 July 2026, medical devices, IVDs, systems and procedure packs placed on the Swiss market must be registered in swissdamed, the Swiss database for medical devices. This also applies to manufacturers based outside Switzerland: their Swiss Authorised Representative (CH-REP) registers the devices for them. Important deadlines 1 July 2026: device registration in swissdamed became mandatory. 31 December 2026: end of the transitional period. Devices placed on the market from 1 July 2026, and existing devices that are still being placed on the market, must be registered by this date at the latest. Vigilance cases: devices affected by a serious incident, a field safety corrective action or a trend report must be registered immediately, without a transitional period. Who registers devices? Swiss manufacturers Swiss persons who assemble systems and procedure packs Swiss...

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 performa...

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 up...

  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 ...

  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 ar...

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 t...