The Swiss Authorized Representative (CH-REP) is needed by the Swiss authorities for medical device and IVD manufacturers located outside of Switzerland. In order to place your products on the Swiss market, you must appoint a Swiss Authorized Representative (CH-REP).As your CH-REP, we will guide you through the Swiss requirements and ensure that you meet all regulatory requirements of the Swiss regulation.Accelerate your market entry in Switzerland with our efficient CH-REP solution - contact us now!
CH-REP: Secure access in the Swiss market
In order to sell your medical devices or in vitro diagnostics (IVDs) in Switzerland as a foreign manufacturer, you need a Swiss authorized representative. A CH-REP is therefore a mandatory requirement for your access to the Swiss market.
What are our tasks and responsibilities as your Swiss authorized representative/CH-REP?
The rights and responsibilities of the Swiss Authorized Representative (CH Rep) are governed by the MepV with references to the EU Medical Device Regulation. They are further detailed and documented in a cooperation agreement between you and us as the Swiss Authorized Representative. In general, as the Swiss Authorized Representative, we undertake the following tasks:
- Review of Declarations of Conformity and Technical Documentation, as well as conformity assessment procedures for the Swiss market.
- Reporting of serious incidents and safety corrective actions to the relevant Swiss authority (Swissmedic) and submission of trend reports.
- Communication with Swissmedic to assist you in ensuring the conformity of your medical devices by taking all necessary measures.
- Coordination of Swissmedic inquiries regarding product samples or the conformity of specific products.
- Cooperation with Swissmedic on all preventive or corrective actions and ensuring collaboration among all involved parties.
- Immediate communication with you as soon as irregularities are detected.
- Verification of compliance with registration requirements for unique product identification and registration of the relevant products.
- Taking over the responsibility to retain your documents in accordance with applicable regulations and as agreed.
How do you benefit from working with us?
In-depth knowledge and many years of experience: With us, you will find a broad-based team with the necessary expertise and experience to meet the regulatory requirements of your medical devices/in vitro diagnostics (IVDs). We are able to identify potential problems at an early stage and find effective solutions.Efficiency and cost savings: Our services save your valuable time and money by eliminating the need to invest in regulatory expertise and infrastructure yourself. We already have the necessary resources and know-how to meet your requirements.Maximum flexibility: With a dedicated team of over 60 permanent employees, we offer you flexible collaboration and are always there for you. Our goal is to provide you with the best possible support, exactly when you need it!Simplify your access to the Swiss market with our CH-REP service - Find out now!