Issue of export certificates (Free Sales Certificates) for medical devices

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.

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.

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Service Agreement

The service agreement describes the services that the Swiss Therapeutic Products Agency provides in terms of issuing Export Certificates for medical devices. It also describes the entitlements and obligations of the persons who make use of this service.

With each order, the service recipient explicitly agrees to the conditions of this service agreement.

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