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How to Choose a Swiss Authorised Representative (CH-REP)

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If your company is based outside Switzerland and you want to place medical devices or IVDs on the Swiss market, you need a Swiss Authorised Representative (CH-REP). Under Art. 51 of the Swiss Medical Devices Ordinance (MedDO), a manufacturer without a registered office in Switzerland may only place a device on the market after appointing a CH-REP based in Switzerland under a written mandate. The same applies to IVDs under the IvDO. An EU Authorised Representative does not replace the CH-REP. Many providers offer this role, from large global consultancies to small Swiss specialists. This guide lists the points that matter most when you compare them. 1. A Swiss address and a registered actor The CH-REP must be established in Switzerland. Its name and address appear on your labelling, so the address must allow Swissmedic and users to contact the representative. According to Swissmedic, a P.O. box, an e-mail address or a phone number alone is not enough. Authorised representatives mus...
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swissdamed Registration Fees 2026: What Manufacturers Pay and What to Do Before 31 December

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Since 1 July 2026, every medical device, IVD, system and procedure pack placed on the Swiss market must be registered in swissdamed, the Swiss medical device database run by Swissmedic. The transition period ends on 31 December 2026 . On that same day, Swissmedic issues its first registration fee invoices. The fee model is simple on paper. In practice, it raises questions: What exactly counts as one registration? Do you pay every year? Who receives the invoice if you are based outside Switzerland? This article answers those questions with worked examples. Key facts at a glance Topic Rule Registration mandatory since 1 July 2026 End of transition period 31 December 2026 No transition period Devices with a reportable serious incident, field safety corrective action (FSCA) or trend Fee basis Per UDI-DI (Basic UDI-DI and package UDI-DIs are free) Fee amount CHF 200 for the first UDI-DI per calendar year, CHF 20 for each further UDI-DI Annual cap CHF 10,000 per manufacturer (...
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CH-Importer in swissdamed: Link Your Devices by 1 April 2027

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Since 1 October 2026, Swiss importers can link their registration to the medical devices and IVDs they place on the Swiss market in swissdamed. Swissmedic gives importers until 1 April 2027 to complete these links. Here is what a CH-Importer has to do now, and what manufacturers should prepare. Importers link, they do not register A CH-Importer does not register devices in swissdamed. Devices are registered by Swiss manufacturers or, for foreign manufacturers, by their Swiss Authorised Representative (CH-REP) . The importer then adds its own details to an already registered device by linking its CHRN (CHRN-IM-…) to the device's UDI-DI. The legal basis is Art. 53 para. 4 MedDO and Art. 46 para. 4 IvDO, each in conjunction with Art. 13 para. 4 of the EU MDR or IVDR. Linking is free of charge for importers. Key dates Date What applies 1 July 2026 Device registration in swissdamed is mandatory 1 October 2026 Linking function for importers is available 31 December 2026 End of ...
Location: Zug, Schweiz
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CH-REP Labelling Requirements: Where and How to Show Your Swiss Representative

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Looking for the CH-REP symbol itself? Our CH-REP symbol guide explains its meaning, the Swissmedic rules and correct and wrong label examples, with links to the official download. 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, pro...
Location: Zug, Schweiz
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Product Registration in Switzerland

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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...
Location: Zug, Schweiz
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Swissmedic: Market Surveillance of Medical Devices

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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...
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Responsibilities of the CH-Importer

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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...
Location: Zug, Schweiz
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Responsibilities of the CH-REP

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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...
Location: Zug, Schweiz
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Impact of the MRA Expiry

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Location: Zug, Schweiz
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What is a CH-Importer? Who needs it?

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  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 ...
Location: Zug, Schweiz
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