New system for issuing Export Certificates (FSC) and Manufacturing Certificates (MC) for medical devices

Announcement about upcoming changes relating to the issuing of Export Certificates (FSC) and Manufacturing Certificates (MC)

Drawing on the results of a fundamental analysis of the process, Swissmedic is completely overhauling the way it issues Export Certificates and Manufacturing Certificates for medical devices. One innovation is the submission of the documents electronically via the Swissmedic Portal.

The new system will be rolled out on 17 September 2018. From this date, Swissmedic will accept the first orders according to the new process.

For the current system, there will be a transitional period lasting until 19 October 2018.

Basics

Initial situation

For decades, Swissmedic has issued Export Certificates and attestations for the Swiss export industry. In recent years the number of orders and the time spent processing each order have steadily increased. Unless countermeasures are taken it will no longer be possible to maintain current timelines in the medium term.

Following an in-depth analysis of the processes, the service has been completely 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.

New service agreement

The new "Service Agreement for the issuing of Export Certificates and Manufacturing Certificates" aims to present the scope of services and the preconditions for the provision of services in a clear and transparent manner. It describes the services provided by Swissmedic in connection with the issuing of Export Certificates and Manufacturing Certificates (attestations). It also describes the entitlements and obligations of the persons who make use of this service.

Upcoming changes

The main features of the new process are as follows:

  • Revised product portfolio: one type of FSC and one type of attestation
  • Scope of services specified in a Service Agreement (SA)
  • Clear requirements for the structured submission of supporting documents and product lists
  • Active PDF order form that updates dynamically during completion
  • Completely overhauled information, instructions and guidance
  • Electronic submission of order form, supporting documents and product lists via the Swissmedic Portal
  • FSC and certifying documents sent to applicant only
  • Fee adjustment on 01.01.2019, when the new Therapeutic Products Fees Ordinance (FeeO) comes into force.

Dates

Introduction of the new system

The new system will be launched two and a half months after this announcement, on 17 September 2018. From this date Swissmedic will accept the first orders under the new process.

There will be a transitional period lasting until 19 October 2018, during which the current system will be simultaneously active.

All orders submitted up to this date will be processed under the current system. After this date, only the new order process will apply.

Comprehensive explanatory documents will be made available for the launch, as will a regularly updated FAQ list. A short video guide will show the individual steps involved in the electronic submission of order documents via the Swissmedic Portal.

Swissmedic plans to publish an English-language explanation on its website in due course for the information of recipient countries of Export Certificates and attestations.

To assist you in your in-house preparations, all the required information and new documents will be published on the Swissmedic website one month before the actual launch.

Questions & answers

Contact

Swissmedic
Division medical devices
Hallerstrasse 7
3012 Berne
Switzerland

Last modification 05.07.2018

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