Your Fast Track to a CH-REP
Your Fast Track to a CH-REP
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With the implementation of Switzerland's MedDO and IvDO in 2021, navigating the regulatory landscape for medical devices and IVDs requires understanding key roles, including the mandatory Swiss Authorised Representative (CH-REP) for foreign manufacturers and the CH-Importer. The CH-Importer, as the Swiss-based entity placing foreign products on the market, faces strict compliance obligations.
Given the complexity and time involved in meeting these requirements without sufficient expertise, clarity on the CH-REP's functions and how they relate to the CH-Importer's responsibilities is paramount for avoiding risks and achieving compliant, smooth market entry.
Our simple and fast 5-step approach
Our simple and fast 5-step approach
After completing these five simple steps, you’ll be ready to sell your products in the Swiss market.
Reach out to us via email or phone.
You will receive the contract and a checklist of the required information.
We will review and verify the information you provide. If you are already MDR/IVDR compliant, this process will be quick and straightforward.
We will guide you through all the necessary steps, with a primary focus on documentation.
Typically, within 10 days after you have
provided us with the information.
50+
Manufactures already trust us for their CH-Importer and CH-REP services.
CH-REP Price List
Both our processes and price structure are simple, transparent, and cost-efficient.
Generally, the services included in our CH-REP packages are more than sufficient for our
customers to enter the Swiss market. Only in rare cases, additional expenses may be
necessary, which will be calculated based on our hourly rate.
CH-REP small
CH-REP small
CHF 99.-/month
Class I (MD) only
Up to 10 devices
Scope of services:
→ Provide labeling guidelines
→ Review compliance
→ Contact for Swissmedic
→ Full vigilance and incident reporting requirements
→ Assistance with required registrations
→ NEW: Compliance Seal & Certificate for your website [more]
Optional or on-demand services:
CHF 199.-/hour
Setup Fee:
CHF 999.-/One time
Key terms of contract:
Cancelable with 3-month notice
CH-REP medium
CH-REP medium
CHF 199.-/month
Class I (MD) only
11-50 devices
Scope of services:
→ Provide labeling guidelines
→ Review compliance
→ Contact for Swissmedic
→ Full vigilance and incident reporting requirements
→ Assistance with required registrations
→ NEW: Compliance Seal & Certificate for your website [more]
Optional or on-demand services:
CHF 199.-/hour
Setup Fee:
CHF 999.-/One time
Key terms of contract:
Cancelable with 3-month notice
CH-REP large
CH-REP large
Price upon request
All Classes (MD) and IVDs
51 or more devices
Scope of services:
→ Provide labeling guidelines
→ Review compliance
→ Contact for Swissmedic
→ Full vigilance and incident reporting requirements
→ Assistance with required registrations
→ NEW: Compliance Seal & Certificate for your website [more]
Optional or on-demand services:
CHF 199.-/hour
Setup Fee:
CHF 999.-/One time
Key terms of contract:
Cancelable with 3-month notice
I want to know more about your CH-REP services!
I want to know more about your CH-REP services!
Do not hesitate to contact our experts today.
Additional Information:
Non-Swiss manufacturers of medical devices and in vitro diagnostics (IVDs) must appoint a CH-REP (Swiss Authorized Representative) to legally sell their products in Switzerland. Since Switzerland is no longer part of the EU’s Mutual Recognition Agreement (MRA), compliance with Swiss medical device regulations (MedDO and IvDO) is mandatory.
A CH-REP serves as the official representative of a foreign manufacturer and acts as the main contact for Swissmedic and other regulatory authorities. The CH-REP ensures that all products meet Swiss legal requirements, including correct labeling, documentation, and post-market surveillance. Without a designated CH-REP, manufacturers outside Switzerland cannot place their medical devices or IVDs on the Swiss market.
Choosing a trusted CH-REP is essential to avoid compliance risks and regulatory issues. The CH-REP is responsible for keeping the Technical Documentation available for Swissmedic, assisting with regulatory inquiries, and ensuring that vigilance and incident reporting obligations are met.
If you need a reliable CH-REP to support your market entry and compliance efforts, we are here to help. Our expert team ensures that your medical devices meet Swiss regulatory requirements, allowing you to focus on business growth. Contact us today to learn more about our CH-REP services. Fast track.
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