Swiss Authorized Rep (CH-REP) Service
Trusted by 250+ medical device & IVD manufacturers across 20 countries
✓ Full Swiss AR setup from contract to ‘swissdamed’ registration in just 2-4 weeks
✓ Fast, responsive support from experienced regulatory professionals
✓ Direct access to your dedicated regulatory contact (no generic inboxes)
✓ Transparent, flat-fee pricing with no hidden costs
New to Swiss requirements? Learn more about the process below ↓
Why You Need a Swiss Authorized Rep
Switzerland and the EU no longer have a valid Mutual Recognition Agreement for medical devices. As a result, an EU Authorized Representative is no longer recognized in Switzerland. Instead, Swissmedic requires its own version – a Switzerland Authorized Representative (AR) for medical devices and IVDs. The Swiss AR is also referred to as a ‘CH REP’.
The Swiss Authorized Representative is responsible for 1) verifying you have CE marked your device, 2) reporting vigilance (serious incidents and FSCAs), and 3) acting as the point of contact between you and Swissmedic when needed.
NOTE: Due to a customs treaty, Liechtenstein-based companies may act as Swiss Authorised Representatives. Further, manufacturers and importers in Liechtenstein are exempt from having to appoint a Swiss AR, though they must meet other obligations, such as obtaining a Swiss Single Registration Number (CHRN).
What does the Swiss AR do?
- Maintain a registered place of business in Switzerland or Liechtenstein
- Puts the Swiss Mandate in place for each manufacturer they represent
- Appoint a Person Responsible for Regulatory Compliance (PRRC)
- Ensure manufacturer has carried out the appropriate conformity assessment process and drawn up the relevant technical documentation
- Have access to the technical documentation in case of a request from Swissmedic
- Be the point of contact between the manufacturer and Swissmedic, where required to do so
- Support with vigilance, including notifying manufacturers of any complaints or reported events and coordination of vigilance reporting to Swissmedic*
*The Swiss Authorized Representative is responsible for ensuring that the manufacturer reports vigilance (serious incidents, FSCAs). This is different from Europe; it is not the EU Authorized Representative’s responsibility to ensure the manufacturer reports vigilance.
Need Help?
Reach out to explore how we can assist with your market entry or provide a tailored quote. We would be happy to schedule a no-obligation call to discuss your needs.
Our Swiss AR Service Process
Complete service from contract to Swissmedic registration in 2-4 weeks.
- Contract & Onboarding (1-3 days): Sign your Swiss AR agreement and provide device technical documents. Our fast onboarding gets you started in days, not weeks.
- Documentation Review (3-5 business days): Casus reviews your technical documentation for completeness. Class I devices and Class A IVDs may take 2-3 weeks if manufacturers need to complete or update technical documentation to meet compliance requirements.
- ‘swissdamed’ Manufacturer Registration (2-3 business days): We submit your manufacturer ‘Actor’ registration to Swissmedic. Device registration does not become mandatory until July 2026.
- Ongoing Support: Direct access to your dedicated regulatory team for questions, updates, and Swissmedic inquiries.
Why Manufacturers Choose Casus
Fast, Responsive Service: Our client onboarding is one of the fastest in the industry, completed in days compared to the weeks (or months) quoted by other providers. High-quality project management means you can be confident about results and timelines.
Transparent, Fair Pricing: No hidden costs or surprise fees. We don’t increase your Swiss AR service fee when you add products later. You’ll receive straightforward, professional service with clear pricing from the start.
Experienced Regulatory Team: We understand how to navigate Swiss requirements efficiently. You will have direct access to knowledgeable regulatory professionals; no intermediaries, junior employees, or ticket systems.
Proven Track Record: Trusted by 250+ medical device and IVD manufacturers across 20 countries for EU, UK, and Swiss regulatory representation services.
Does the Swiss AR need to be on the labeling?
Yes. The Swiss Authorised Representative is required on the device labeling (or document accompanying the device, for certain products).
There is a Swissmedic CH-REP symbol available for use, similar in design to the EC-REP symbol. No minimum size has been defined, other than that it must be clearly legible to the naked eye. The CH-REP logo is available in various formats.
To download the CH-REP symbol, click here and then scroll to the bottom of the Swissmedic webpage.
The requirement on where to place the AR information on the label depends on EU Directive/Regulation leveraged.
Do I need to register my devices with Swissmedic?
Swissmedic only requires device registration for certain devices manufactured by Swiss manufacturers, such as Class I medical devices and IVDs. Non-Swiss manufacturers do not, and should not, register their devices* with Swissmedic.
NOTE: Swissmedic is in the process of developing a new registration database, which will be similar to the European Database on Medical Devices (EUDAMED), called swissdamed. The Swiss Actor Registration module became mandatory as of August 6, 2024 and the Medical Device module will become mandatory starting July 1, 2026.
*The exception is for custom-made devices, which should be registered irrespective of where the manufacturer is located.
