The Swiss Authorized Representative (CH-REP) is required by the Swiss authorities for medical device and IVD manufacturers located outside Switzerland. In order to place your products on the Swiss market, you must appoint a Swiss Authorized Representative (CH-REP).We are registered in swissdamed as a Swiss Authorized Representative under the registration number CHRN-AR-20003994. As your CH-REP, we will guide you through the regulatory requirements and ensure that you fulfill all obligations 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 obligations of the Swiss Authorized Representative (CH-REP) are governed by MepV and IvDV with references to the Medical Device Regulation (MDR) and the Regulation on In-vitro Diagnostic Medical Devices (IVDR) of the European Union. The CH-REP is responsible for regulatory and safety issues related to placing your products on the market in Switzerland.How these rights and obligations are exercised is further detailed and recorded in a cooperation agreement between you as the manufacturer and us as the Swiss authorized representative. In principle, we as CH-REP take on the following tasks:
- Verification that the declaration of conformity and technical documentation have been drawn up and, if applicable, that an appropriate conformity assessment procedure has been carried out.
- Verification that the products concerned have been registered and that the information is up to date.
- Ensuring that the necessary reports are made to Swissmedic as part of the vigilance procedure. This includes serious incidents, FSCAs and trend reporting.
- Providing the safety report (PSUR) at the request of a Swiss authority.
- Cooperation with Swissmedic on all corrective and preventive actions to be taken by you as a manufacturer to prevent or mitigate risks of your medical devices.
- Immediate forwarding of complaints and user reports on suspected serious incidents received by Swissmedic to you as the manufacturer.
- Coordination of inquiries from Swissmedic regarding product samples or access to a product.
- Assuming your storage obligations as agreed upon and enabling Swissmedic to access the current technical documentation and all necessary information and documents relating to the conformity of your products in a timely manner.
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!
