Setting up a medtech company or acting as Swiss authorised representative in Geneva: MedDO, CHRN, importer and distributor duties

Medical device or medicinal product: settle it first

Before you set up a medical device company in Geneva, the product has to be qualified, because the rest of the file depends on it. Under the Medical Devices Ordinance (MedDO), a medical device is an instrument, apparatus, software, implant or similar article intended for a medical purpose in humans that does “not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means” (Art. 3 MedDO). A product that works pharmacologically is a medicinal product, which brings a Swissmedic licence, a responsible person and an inspected site: that scenario is covered in our article on setting up a pharmaceutical company in Geneva.

For devices, Swissmedic leaves no ambiguity: “Unlike medicinal products, medical devices do not undergo an official authorisation procedure.” The agency monitors the market instead of licensing it. The counterpart is strict: manufacturers, representatives, importers and distributors may only place devices on the market or put them into service “when the applicable conformity assessment procedure has been successfully completed”, and Swissmedic states that this also covers devices “given away free of charge, rented or used directly”.

A foreign manufacturer selling in Switzerland: what must exist in Geneva

Switzerland and the European Union no longer apply an up-to-date mutual recognition agreement for medical devices. The Federal Office of Public Health draws the consequence: “Switzerland is therefore currently treated as a third country, but unilaterally recognises EU conformity assessments.” A CE marking remains a permissible conformity marking in Switzerland (Art. 13 para. 1 MedDO), so the product itself does not need to be re-certified. What changes is the chain of Swiss operators around it, whether the manufacturer sits in Lyon, London, Boston or Shenzhen.

The representative and the importer are distinct roles. An importer is any person “domiciled in Switzerland that places a device from a foreign country on the Swiss market” (Art. 4 MedDO). A Geneva company that buys devices from its foreign parent or supplier and resells them in Switzerland is therefore an importer, whatever its contracts call it. Before the first sale it checks the conformity marking, the declaration of conformity, the labelling and whether the manufacturer “has designated an authorised representative in accordance with Article 51” (Art. 53 MedDO). One Geneva entity can hold both roles for the same manufacturer, which is often the most coherent set-up for a foreign group opening a Swiss subsidiary.

Acting as Swiss authorised representative from Geneva

“Where the manufacturer of a device is not domiciled in Switzerland, the device may only be placed on the market if the manufacturer designates an authorised representative domiciled in Switzerland by means of a written mandate” (Art. 51 para. 1 MedDO). For a Geneva company, representing several manufacturers can become a business line in its own right. It is not a mailbox service.

• Regulatory responsibility: the representative “is responsible for the formal and safety-related aspects of placing the device on the market” (Art. 51 para. 2 MedDO).
• Seven-day rule: where the mandate provides that the manufacturer sends its technical documentation directly to Swissmedic, the representative “must ensure that the documentation is submitted within seven days” (Art. 51 para. 4 MedDO).
• Qualified person: the representative must have “permanently and continuously at their disposal” at least one person responsible for regulatory compliance, known as the PRRC (Art. 52 MedDO).
• Mandate scope: Swissmedic specifies that a designation must cover at least all devices of the same generic device group.
• Labelling: the representative’s name and address “must appear adjacent to the symbol”; a P.O. box, an e-mail address or a telephone number alone is not enough, according to Swissmedic.

The CHRN starts at the commercial register

Representatives and importers register with Swissmedic before the first placing on the market, and Swissmedic assigns them a Swiss single registration number, the CHRN (Art. 55 MedDO). The request is filed in the Actors module of swissdamed, and Swissmedic requires that “Evidence of domicile in Switzerland (i.e. extract from the commercial register or certificate of residence) must be attached to the application.” The Geneva company is therefore incorporated and entered in the commercial register before any registration can take place.

Since 1 July 2026, the devices themselves must also be registered in swissdamed, with a transition period until 31 December 2026. Swissmedic charges CHF 300 per notification for the notifications listed in the MedDO, including those under Art. 53, 54 and 108: a cost that a representative managing several product ranges should build into its fees.

Risk class, invasive devices and notified bodies

The class of a device does not change the representative’s duties, but it determines the manufacturer’s route to market and therefore the timetable of any Geneva project. Devices “shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks” (Art. 15 MedDO), following Annex VIII to the EU Medical Device Regulation (EU-MDR). Swissmedic recalls that classifying the device correctly is the manufacturer’s responsibility.

Two criteria weigh most. The first is invasiveness: the EU-MDR describes an invasive device as one “which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body”. The second is the duration of continuous use: transient below 60 minutes, short term up to 30 days, long term beyond.

• Non-invasive devices: class I in principle, unless a specific rule applies.
• Invasive through a body orifice: class I for transient use, IIa for short-term use and IIb for long-term use, with lower classes for the mouth, ear canal and nasal cavity.
• Surgically invasive devices: generally IIa for transient or short-term use; reusable surgical instruments stay in class I, and direct contact with the heart, central circulatory system or central nervous system means class III.
• Implantable and long-term surgically invasive devices: generally IIb, and class III for active implants, breast implants, joint or spinal disc replacements among others.

In class I, the manufacturer issues its own declaration of conformity once the technical documentation is ready, with a limited notified body review for sterile devices, devices with a measuring function and reusable surgical instruments (Art. 52 para. 7 EU-MDR). Above class I, a notified body assesses conformity, and Swissmedic’s list is short: “As of 1 April 2025, there are no designated bodies in Switzerland.” A Geneva manufacturer of invasive devices works with a notified body established in the European Union.

Manufacturing in Geneva and selling in the EU

For a Geneva company, the border works in both directions. Art. 11 para. 1 EU-MDR provides that “Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.” A Geneva manufacturer supplying clinics in Annemasse, Lyon or Milan therefore appoints an authorised representative established in the EU, on top of the notified body required above class I.

A company that has a device produced by a subcontractor and markets it under its own brand is the manufacturer within the meaning of Art. 4 MedDO. It must have a PRRC within its organisation, with a deputy (Art. 49 MedDO). Micro and small enterprises may use an external PRRC, provided they “have such person permanently and continuously at their disposal” (Art. 15 para. 2 EU-MDR), which is often the arrangement a Geneva start-up chooses in its first years, documented by contract. Swissmedic adds that the MedDO does not require the PRRC to be domiciled in Switzerland, provided the person is integrated in the organisation over the long term.

If development requires a clinical investigation in Switzerland, the procedure depends on the device. Category A trials concern devices that already carry a conformity marking and are used according to their instructions: under Art. 7 of the Ordinance on Clinical Trials with Medical Devices (ClinO-MD), they need no Swissmedic approval. Category C trials, on unmarked devices or devices used otherwise, require Swissmedic approval as well as the ethics committee.

Office, workshop or cleanroom: the OCIRT review

A representative or an importer works from offices. A manufacturer that assembles, packages or sterilises devices in Geneva needs suitable premises, and labour law comes into play. A company classified as industrial, or carrying out one of the activities listed in Ordinance 4 to the Labour Act, has its plans approved by the cantonal authority before fitting out.

In Geneva, that review belongs to the Cantonal Office for Labour Inspection and Relations (OCIRT). Large projects and industrial companies are seen by appointment, which the canton says is in principle granted within two weeks. For industrial companies, the OCIRT issues a decision authorising the fit-out, taking the opinion of SUVA, then an operating authorisation after an inspection visit when operations begin. Industrial zones are managed by the Foundation for Industrial Land in Geneva (FTI). Building a cleanroom before this review risks having to redo the works.

Customs, VAT and Geneva taxation of a medtech company

• Customs: since 1 January 2024, Switzerland no longer levies customs duties on industrial goods in chapters 25 to 97 of the Harmonised System, which include medical instruments and apparatus. Devices bought in France, the United States or Asia enter duty-free, but a customs declaration and import VAT remain, as our guide to importing into Switzerland explains.
• VAT: the reduced rate of 2.6% applies to “medication” (Art. 25 para. 2 VAT Act); medical devices fall under the standard rate of 8.1%. Medical treatment is excluded from VAT, but “The dispensing of self-manufactured or bought-in artificial limbs and orthopaedic equipment is deemed to be a taxable supply of goods” (Art. 21 para. 2 VAT Act), so a Geneva supplier charges VAT to the clinic or practice it delivers. Our complete guide to VAT in Switzerland covers registration and input tax recovery.
• Research and patents: Geneva grants an additional deduction of 50% of research and development expenses, but only a 10% reduction on profits from patents, against 90% in Zurich, Zug or Lucerne and 60% in Vaud. We explain both mechanisms in our article on starting a SaaS start-up in Geneva.

The legal form follows the role and the financing. A GmbH (Sàrl) is often enough for a representative or an importer, while a company limited by shares (AG/SA) accommodates investors more easily. We compare both in our GmbH or AG in Geneva comparison.

Mistakes we see on medtech files

• Assuming CE marking settles everything: the marking is recognised, but the Swiss representative and the importer remain mandatory for any manufacturer established outside Switzerland.
• Accepting a CH-REP mandate on a domiciliation address: without a PRRC available at all times and a procedure to obtain the technical documentation within seven days, the role cannot be performed.
• Underestimating the class of an invasive device: the need for a notified body, now outside Switzerland, is discovered late.
• Forgetting the return journey: a Geneva start-up targeting French hospitals without an authorised representative in the EU.
• Fitting out before the OCIRT review: a workshop or cleanroom built before checking whether the plans require approval.

FAQ: setting up a medical device company in Geneva

Can a Geneva company act as Swiss authorised representative for a foreign manufacturer?

Yes. A manufacturer not domiciled in Switzerland must designate an authorised representative domiciled in Switzerland by written mandate (Art. 51 MedDO), and a Geneva company can take on that role. It registers with Swissmedic, appears with its name and address next to the CH-REP symbol and must have a PRRC permanently at its disposal.

Does a foreign manufacturer also need an importer in Switzerland?

Yes, as soon as a device from abroad is placed on the Swiss market. The importer is the person domiciled in Switzerland that places it on the market: it verifies the conformity marking, the declaration of conformity and the designation of the representative, then adds its own name and address to the device or its packaging. One company can be both representative and importer.

Is a domiciliation address in Geneva enough to obtain a CHRN?

The application requires evidence of domicile in Switzerland, such as a commercial register extract, which a domiciled company can provide. The CHRN does not create the organisation, though: a representative must be able to answer Swissmedic, obtain the technical documentation within seven days and rely on a qualified person at all times.

Can a Geneva manufacturer sell its devices in France or elsewhere in the EU?

Yes, under the EU rules for manufacturers established outside the Union: a sole authorised representative established in a Member State and, above class I, an assessment by a notified body. Since 1 April 2025, there has been no designated body left in Switzerland.

Is an invasive medical device always in a high class?

No. A device invasive through a body orifice and used for less than 60 minutes, or a reusable surgical instrument for transient use, is in principle class I. Surgically invasive and implantable devices move to class IIa, IIb or III depending on duration of use and the part of the body concerned, and classification is the manufacturer’s responsibility.

What VAT applies to medical devices imported into Geneva?

The standard rate of 8.1%, since the reduced rate is reserved for medication. No customs duty has been charged on these industrial goods since 1 January 2024, but import VAT is due at customs clearance and can be recovered as input tax by a VAT-registered company.

Sources

• Medical Devices Ordinance (MedDO, SR 812.213), Art. 3, 4, 13, 15, 16, 49, 51 to 53 and 55
• Regulation (EU) 2017/745 on medical devices, Art. 2, 11, 15, 52 and Annex VIII
• Swissmedic, Market access
• Swissmedic, Registering economic operators (CHRN)
• Swissmedic, Swiss authorised representative (CH-REP)
• Swissmedic, Notification and registration of medical devices
• Swissmedic, Designated bodies
• Swissmedic, Frequently asked questions on medical devices
• Federal Office of Public Health, Medical devices
• Ordinance on Clinical Trials with Medical Devices (ClinO-MD, SR 810.306), Art. 6 and 7
• Federal Act on Value Added Tax (VAT Act, SR 641.20), Art. 21 and 25
• Canton of Geneva, Having plans reviewed and approved by the OCIRT (in French)