A new system for issuing Export Certificates (FSC) and Manufacturing Certificates (MC) for medical devices in Switzerland

Aug 2018

For decades, Swissmedic has issued Export Certificates and attestations for the Swiss export industry. Recently, the number of orders and the time spent processing each order have steadily increased. Countermeasures are required in order to maintain current timelines in the medium term.

Following an in-depth analysis of the processes, the service has been thoroughly redesigned. This redesign has also taken account of the new technical resources that were recently made available to the Medical Devices Division including, in particular, the use of the Swissmedic Portal for electronic order submission.

The main characteristics of the new process are:

Revised product portfolio: one type of Export Certificates (FSC) and one type of attestation (Manufacturing Certificates)
The scope of services specified in a Service Agreement (SA), which aims to present the scope of services and the preconditions for the provision of services in a clear and transparent manner. Furthermore, it describes the services provided by Swissmedic related to the issuing of Export Certificates and Manufacturing Certificates (attestations). It also explains the entitlements and obligations of the persons who make use of this service
Precise requirements for the structured submission of supporting documents and product lists
Active PDF order form that updates dynamically during completion
Wholly overhauled information, instructions and guidance
Electronic submission of the order form, supporting documents and product lists via the Swissmedic Portal
Export Certificates (FSC) and certifying documents sent to the applicant only
Fee adjustment on 01.01.2019, when the new Therapeutic Products Fees Ordinance (FeeO) comes into force

The new system will be launched on the 17th of September, 2018. From this date, Swissmedic will accept the first orders under the new process. However, there will be a transitional period lasting until the 19th of October 2018, during which the current system will be simultaneously active.

See the full report in English (change to Italian, French or German in the top-right corner) here.

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