Medical device manufacturers who do not have their registered office in Switzerland require an authorised representative in Switzerland (CH-REP) to comply with the legal requirements and regulations of the country. Switzerland has specific regulations and laws for medical devices that manufacturers must comply with.
- A CH-REP is the contact person for the competent authorities and ensures the duty of cooperation of economic operators.
- A CH-REP helps to ensure that the company can provide all the necessary documents and certifications and complies with the regulatory requirements.
BEO BERLIN organises and supervises your CH-REP within the framework of the network. We offer this service through our long-standing partner based in Switzerland. After positive evaluation of the conformity of the relevant products, the qualified employee of Albo-Healthcare will register them as Swiss Authorised Representative at Swissmedic.
Do you have questions on this topic?
BEO BERLIN supports manufacturers with regulatory questions relating to MDR, technical documentation and market access.
