Contact us for Swiss Market Access Support:

CHREP.me supports non-Swiss medical device manufacturers, distributors and dealers with Swiss Authorised Representative and Swiss Importer (CH-Importer) services for Switzerland. Our team provides practical support for Swiss market access, including Swiss Authorised Representative requirements, importer obligations, swissdamed-related processes and compliance with the applicable MedDO and IvDO requirements.

If you have questions about Swiss Authorised Representative Swiss Importer (CH-Importer) services or the regulatory requirements for selling medical devices and IVDs in Switzerland, contact our team for practical and transparent support.

Manufacturers and distributors based outside Switzerland generally need a Swiss Authorised Representative and, depending on the distribution model, a Swiss Importer (CH-Importer). For details on these requirements, see our Swiss Authorised Representative and Swiss Importer pages.

When you contact us, it helps to let us know your device class, your current distribution setup in Switzerland, and whether you already work with a Swiss Authorised Representative or Swiss Importer. Sharing this information upfront allows our team to give you a precise, relevant answer with our first response, rather than a longer exchange of clarifying questions. We typically reply within one to two business days by email, and we are happy to schedule a short call instead if your situation would benefit from a direct conversation rather than written correspondence.

Common topics manufacturers ask us about include the practical difference between Swiss Authorised Representative and CH-Importer obligations, the documentation required before a device can be placed on the Swiss market, expected timelines for registration in swissdamed, and how ongoing obligations such as market surveillance, vigilance and incident reporting are handled once a device is already being sold in Switzerland. If your question relates to a specific product, please have the device classification and the relevant technical documentation available when you reach out, as this allows us to give you an accurate, usable answer without unnecessary back-and-forth.

We work with manufacturers of Class I, IIa, IIb and III medical devices as well as IVDs, as well es distributors for medical products, and we are familiar with the practical challenges that arise when a company is entering the Swiss market for the first time. Whatever stage you are at, our team is available to answer questions in plain, non-technical language wherever possible.