CH-REP - Regulatory Affairs - QbD Group (2)

Swiss Authorised Representative (CH-REP) Services

Placing medical devices or IVDs on the Swiss market? You need a Swiss Authorised Representative (CH-REP). QbD Group helps non-Swiss manufacturers meet MedDO and IvDO requirements and ensures your products comply with Swiss regulations. Ensure compliant entry into Switzerland with confidence.

Since Switzerland is not part of the EU regulatory framework, manufacturers based outside Switzerland must appoint a Swiss Authorised Representative (CH-REP) to place medical devices and IVDs on the Swiss market. This obligation is outlined in the Swiss Medical Devices Ordinance (MedDO, SR 812.213) and the In Vitro Diagnostic Medical Devices Ordinance (IvDO, SR 812.219).

Qarad Suisse S.A. – part of the QbD Group – brings over 20 years of experience in MD and IVD representation as an EU and UK authorized representative. Operating from Switzerland, our dedicated team combines strong regulatory and technical expertise to ensure full Swissmedic compliance. We act as your reliable CH-REP throughout the entire product lifecycle.

What is a CH-REP and who needs one?

A Swiss Authorised Representative (CH-REP) is a natural or legal person based in Switzerland who acts on behalf of a non-Swiss manufacturer. The CH-REP ensures your device meets Swiss regulatory obligations, communicates with Swissmedic, and keeps documentation audit-ready.

Manufacture medical devices or IVDs outside of Switzerland

Want to sell devices in Switzerland post-MRA update

Require local representation for compliance with MedDO and IvDO

How can we help you as a CH-REP?

Qarad Suisse S.A. ensures compliance through local representation and direct communication with Swissmedic. We act as your reliable partner throughout the entire lifecycle of your device.

Our Role as Your Swiss Authorised Representative As your CH-REP, we will:

Verify your Declaration of Conformity and technical documentation
Retain copies of your technical documentation and certificates for at least 10 years
Provide Swissmedic with documentation upon request
Ensure your product registration and labelling meet Swiss requirements
Submit documentation to Swissmedic if required and meet any deadlines
Communicate and act on Swissmedic requests for corrective actions, product information, or complaints

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Our 3-step onboarding process

Need assistance? Get in touch.

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1. Mandate & setup

We sign your CH-REP agreement and assess your documentation.

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Regulatory check

We verify compliance with Swiss-specific requirements.

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Official representation

We act on your behalf with Swissmedic and maintain your audit readiness.

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Why partner with QbD Group?

Proven experience: Over 20 years of trusted representation across Europe and Switzerland
Regulatory experts: Skilled in Swiss regulations and experienced in Swissmedic communication
Independent partner: We maintain separation from your importer or distributor
EU alignment: We work according to MDR/IVDR principles, easing dual-market strategies
Trusted by leading manufacturers: Over 100 companies worldwide rely on us

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CH-REP Frequently Asked Questions

Is CH-REP similar to an EU-REP?

Yes, the CH-REP mirrors the EU-REP role in terms of scope and responsibilities, adapted to Swiss national laws.

Should CH-REP details appear on labelling?

Yes, the CH-REP data must be added to the device. Depending on the class of the medical device, the CH-REP details must be included on the label and/or in the instructions for use or in a document accompanying the device. Deadlines for adding the CH-REP details also depend on the class of the device.

Can one partner support both EU and Swiss requirements?

Absolutely. QbD Group covers EU-REP, UKRP, and CH-REP needs through one integrated team.

According to the MDR, I have older devices for which I have a valid certificate from a notified body. Do I need to designate a CH-REP for these devices as well to access the Swiss market?

All other foreign manufacturers must designate a Swiss Authorized Representative effective May 26, 2021. These provisions apply to both MDD/AIMDD and MDR devices.

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Get in touch with our CH-REP experts

Want a reliable Swiss representative to secure your market access? QbD Group is ready to support your regulatory journey. Contact us for more information or request a free, no-obligation proposal.