Swiss Authorised Representative for foreign manufacturers
CH-REP.com assumes the following roles on behalf of the foreign manufacturers:
- Ensuring all regulatory requirements are met by the importer
- Act as Swiss Authorized Representative
- A Check list for the purpose of a "Self-assessment” by the foreign manufacturer.
- Review of the "Self-assessment” completed and of the other returned documentations by the foreign manufacturer.
- Mandate: Provision and delivery of "Importer" and "Swiss Authorised Representative" contract with foreign manufacturer; signing of contract / mandate; preparation of registration (with Swissmedic) manufacturer; registration as importer and Swiss Authorised Representative with Swissmedic.
- Basic services: Fulfilment of the services according to the contract.
We advise and support Swiss distributors in all matters relating to the "Swiss Authorised Representative".
Where appropriate and possible, the distributor can assume the role of "importer" and "Swiss Authorised Representative" himself or at least recommend this to the foreign manufacturer. In this case CH-REP.com supports the (designated) "Swiss Authorised Representative" as follows:
- Partner for all questions regarding the quality management system and the additional processes for performing the aforementioned roles.
- Support in drawing up the contract with the foreign manufacturer.
- Ensure the role of "person responsible for compliance".