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.
Swissmedic is receiving increasing numbers of incomplete orders, which result in additional work. To reduce or compensate for this additional work, the process for issuing FSC certificates is changing with effect from 01.01.2023. Any ordering party that submits an incomplete application have a deadline of 30 days to submit a complete version. If the application is not submitted in full by the deadline or the additional documents issued are not complete or incorrect, Swissmedic will not deal with the application and will remove it from the business directory. The ordering party will then be invoiced a flat fee of CHF 100. This corresponds to half of the fee for an FSC certificate (see Annex 2 GebV-Swissmedic). To obtain the FSC in this case, you must place a completely new order with all the necessary information and documentation.
Please note that as the regulatory authority for medical devices, Swissmedic does not offer any advisory services regarding the development, qualification, registration, conformity and marketing of medical devices. This also applies to advice on ordering FSC certificates. Please contact a private consultancy or the umbrella organisation for your industry directly in this regard. For example, Swiss Medtech (https://www.swiss-medtech.ch) offers its members certain services.
You can find all information and documents on our website Export certificates (FSC) and other certificates (swissmedic.ch).