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Swiss Authorised Representative (CH-REP) Services
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 serves as the official point of contact with Swissmedic, holds the required documentation available for inspection, and supports the manufacturer in meeting Swiss regulatory requirements.

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:
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Verify the manufacturer has drawn up the Declaration of Conformity and technical documentation
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Retain copies of your technical documentation and certificates for at least 10 years
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Provide Swissmedic with documentation upon request
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Ensure your product registration and labelling meet Swiss requirements
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Submit documentation to Swissmedic if required and meet any deadlines
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Communicate and act on Swissmedic requests for corrective actions, product information, or complaints
Our 3-step onboarding process

Why partner with QbD Group?
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Proven experience: Over 20 years of trusted representation across Europe and Switzerland
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Regulatory experts: Skilled in Swiss regulations and experienced in Swissmedic communication
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Independent partner: We maintain separation from your importer or distributor
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EU alignment: We work according to MDR/IVDR principles, easing dual-market strategies
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Trusted by leading manufacturers: Over 100 companies worldwide rely on us
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.
Do I need to designate a CH-REP for legacy devices for which I have a valid certificate from a notified body to access the Swiss market?
All foreign manufacturers must designate a Swiss Authorized Representative. These provisions apply to both legacy devices as well as MDR/IVDR devices.
Get in touch
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.
Authorized Representative Services for the EU and UK
Do you want to appoint an Authorised Representative to sell your products in the UK or the EU?
Find out more about our European and UK representative services:
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