Issue of export certificates (Free Sales Certificates) and Manufacturing Certificates (MC) 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 and in the contracting states. The marketability of medical devices derived from devitalised human tissue, or which incorporate such tissue, is certified only for Switzerland.

Swissmedic does not issue FSC 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. 

Manufacturing Certificate (MC)
The Manufacturing Certificate confirms to the Agency that the ordering company is based in Switzerland, operates a certified quality management system, is a contract manufacturer of medical devices, or parts thereof, and manufactures these for a medical devices manufacturer (based in Switzerland or other country).

To order a Free Sales Certificate or Manufacturing Certificate, please complete the electronic order form and provide all the corresponding documentation (e.g. EC certificate, ISO 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.

Service Agreement

The service agreement describes the services that the Swiss Therapeutic Products Agency provides in terms of issuing Export Certificates and Manufacturing 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.

Questions & answers