CH-REP & Swiss Importer for Non-Swiss Medical Device Manufacturers

Supplying Medical Devices

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Swiss Medical Device Requirements for Non-Swiss Manufacturers

CH-REP and Swiss Importer Requirements in Switzerland

Two Key Roles for Non-Swiss Medical Device Manufacturers Entering the Swiss Market:

Foreign medical device and IVD manufacturers placing products on the Swiss market must comply with specific Swiss regulatory requirements. Depending on their role in the supply chain, this includes appointing a Swiss Authorised Representative (CH-REP), working with a Swiss Importer and ensuring the required registrations in swissdamed. The CH-REP acts as the manufacturer’s regulatory representative in Switzerland and serves as a point of contact for the Swiss authorities. The Swiss Importer has its own role.

CH-REP – Swiss Authorised Representative

The CH-REP (Swiss Authorised Representative) acts as the regulatory link between non-Swiss manufacturers of medical devices or in vitro diagnostics and the Swiss authorities. The CH-REP is established in Switzerland and represents the manufacturer in relation to specific regulatory obligations under Swiss medical device law. For manufacturers based outside Switzerland, appointing a CH-REP is a key requirement for compliant market access where such representation is required.

Icon showing a group of people – symbolizing the representation of a foreign manufacturer in Switzerland.

Swiss flag icon – indicating the company's location in Switzerland for regulatory compliance.

Handshake infront of building – representing expertise as a Person Responsible for Regulatory Compliance (PRRC) for medical devices and in vitro diagnostics

Clipboard with a checkmark – symbolizing the verification of a manufacturer’s registration obligations.

Document with a pen – representing the registration of complaints, non-compliant products, product recalls, and withdrawals.

Document with an exclamation mark – symbolizing the reporting of serious incidents and corrective measures

Represents a non-Swiss manufacturer under a written mandate

Established in Switzerland

Has access to the required regulatory expertise (Person Responsible for Regulatory Compliance)

Verifies the manufacturer’s regulatory and registration obligations

Handles complaints, non-conformities, recalls and withdrawals

Reports serious incidents and corrective measures

Checklist document icon – indicating official registration with Swissmedic and an individual Swiss registration number (CHRN).

Hand holding a gear – symbolizing responsibility for formal and safety-related matters

Hand holding a checklist – representing the review of declarations of conformity, technical documentation, and conformity assessment procedures.

Speech bubble with an exclamation mark – symbolizing the redirection of complaints and reports of suspected incidents.

Handshake with a globe – representing cooperation with Swissmedic on preventive or corrective actions

Registered with Swissmedic and has a Swiss

individual registration number (CHRN)

Responsible for formal and safety-related matters

Reviews declarations of conformity, technical documentation, and conformity assessment procedures

Redirects complaints and reports of suspected incidents

Cooperates with Swissmedic on all preventive or corrective actions

CH-REP Services & Pricing

Our transparent and cost-effective pricing structure.

Swiss Importer – CH-Importer

The Swiss Importer is an economic operator established in Switzerland that places medical devices or IVDs from a non-Swiss manufacturer on the Swiss market. Before placing a device on the market, the importer must verify that the applicable Swiss regulatory requirements are met. In swissdamed, importers do not register devices themselves; they link their importer actor to devices that have already been registered.