Swiss Authorized Representative (CH-REP)
Access the Swiss medical device market
Manufacturers based outside Switzerland must appoint a Swiss Authorised Representative to place medical devices and IVDs on the Swiss market.
What is a CH-REP and who needs one?
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. Based in Switzerland, our dedicated team combines strong regulatory and technical expertise to support manufacturers.
How we support you
We act as your reliable CH-REP and official contact with Swissmedic throughout the entire product lifecycle.
Swiss market access
Enable compliant access to the Swiss medical device and IVD market.
Swissmedic liaison
Serve as your official point of contact with Swissmedic.
Device registration
Handle device registration and notification requirements.
Post-market compliance
Manage vigilance reporting and post-market obligations in Switzerland.
Why QbD Group
Your trusted partner
Part of the QbD Group, Qarad Suisse S.A. brings deep expertise in Swiss medical device regulations.
Swiss-based team with direct Swissmedic experience.
Over 20 years of experience in MD and IVD representation.
Full lifecycle support from registration through post-market compliance.
Part of the broader QbD Group regulatory network.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.