CH REP

CMC Medical Devices offers Swiss authorized representative (CH REP) services for medical devices

We offer Representation services in Switzerland (CH REP) to ensure that your products comply with Swiss regulations and are effectively introduced into the Swiss market.

Swiss Authorized Representative

We can help you

It refers to a specific task where a natural or legal person established in Switzerland receives and accepts a written authorization from a manufacturer located outside Switzerland to fulfill its obligations under Swiss Medical Device Regulations on behalf of the manufacturer. Therefore, non-Swiss manufacturers will need to designate an authorized Swiss representative and an importer in Switzerland.

CMC Medical Devices GmbH, located in Switzerland, has a professional regulatory team and acts as an authorized representative in Switzerland. It maintains close communication and cooperation with SWISSMEDIC and the authorities, carrying out the manufacturer’s corresponding tasks as per official instructions.

Our functions as Swiss Authorized Representative

Verify that the declaration of conformity and technical documentation have been prepared, and if applicable, that an appropriate conformity assessment procedure has been conducted by the manufacturer.
Initial registration with Swissmedic of our mandate and the GMDNs covered by it.
In response to a request from the competent authority, provide all necessary information and documentation to demonstrate device compliance within 7 days.
Forward to the manufacturer any request for samples or access to a device from a competent authority and verify that the competent authority receives the samples or has access to the device.

Cooperate with competent authorities in any preventive or corrective actions taken to eliminate, or if not possible, mitigate risks posed by the devices.
Notification of incidents to Swissmedic based on information provided by the manufacturer.
Notification of incidents to the manufacturer based on information provided by Swiss authorities or the Swiss market.
Contact the manufacturer regarding a special request/problem from Swissmedic.

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Frequently asked questions about Swiss Representative

Why do you need an Swiss Authorized Representative (CH REP)?

Since Switzerland and the European Union have not updated the Mutual Recognition Agreement in relation to the MDR and IVDR, manufacturers not based in Switzerland must appoint a Swiss-based Authorized Representative (CH-REP) to market their medical devices and in vitro diagnostic devices in the country.

At CMC Medical Devices, we can serve as your Authorized Representative in Switzerland. Our team of regulatory experts is prepared to assist you in meeting Swiss regulations, ensuring that your products are compliant and ready for the Swiss market.

Why appoint CMC Medical Devices as you CH-REP?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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