Medicinal products may only be distributed in Switzerland if they are authorised by Swissmedic. The Swiss Agency for Therapeutic Products, is involved in the entire life cycle of a medicinal products because of its mandated areas of responsibility in the sectors of licensing and the authorisation and monitoring of medicinal products.
Export certificates (Free Sales Certificates, FSC)
are issued solely for products that are defined as medical devices under the terms of the Swiss legislation and for which a certificate of conformity is available, making them marketable in Switzerland
Swissmedic does not issue FSCs for veterinary medical devices or products that are defined as medical devices only in the country of destination, e.g. toothbrushes, instruments for dental laboratories, general laboratory equipment etc.
To order a Free Sales Certificate, please complete the electronic order form and provide all the corresponding documentation (e.g. EC certificate, declaration of conformity, product list in compliance with the requirements of our information sheet, etc.). All orders are submitted electronically with our constantly updated order form.
Please note, that an administrative fee (Art. 4 GebV-Swissmedic) of CHF 200 per hour will be charged for additional administrative work, e.g. due to incomplete or inappropriate documentation sent repeatedly, withdrawal of an order after work has already been carried out or requests for information.
Further information on the ordering process and the documentation for the Agency can be found stated below.
The order form and all supporting documents are sent via the Swissmedic web portal www.swissmedic.ch/emessage-en
Adaptation of the ordering process from 01.01.2023
Swissmedic issues FSC export certificates to manufacturers and authorised representatives based in Switzerland, provided that they submit the required documentation with the relevant order form. They can submit orders via our eGov portal with the help of the information on our website, such as guidelines, order forms, FAQs, video, etc.
Forms and instructions
Information sheet
Order form
Support
Instructions
Login/self-registration eMessage