Unternavigation

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.

The order form and all supporting documents are sent via the Swissmedic web portal www.swissmedic.ch/emessage-en

Troubleshooting for PDF forms

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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Information sheet

OS000_00_005e_MB eMessage functions (PDF, 483 kB, 30.05.2024)

BW690_00_002e_WL Export Certificates (PDF, 508 kB, 26.05.2025)

BW690_00_001e_WL Service Agreement Export Certificates MEP (PDF, 1 MB, 08.11.2023)

Order form

BW690_00_001defi_FO Orders for export certificates for medical devices (PDF, 1 MB, 26.05.2025)

BW690_00_002defi_FO Orders for export certificates for medical devices subject to old legislation as well as DEVIT products and IVD (PDF, 1 MB, 03.04.2025)

Support

BW690_00_001e_VL FSC-Example of a product list (PDF, 287 kB, 25.03.2025)

Troubleshooting for PDF forms

Instructions

Free Sales Certificates

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Replies/submissions through eGov Service eMessage

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www.swissmedic.ch/emessage-en

eGov Service eMessage

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.

BW690_00_001e_WL Service Agreement Export Certificates MEP (PDF, 1 MB, 08.11.2023)

Why can a production location no longer be indicated on the Free Sales Certificate?

This option has no longer been available on the order form since 26 May 2021 (due to a change in the law) and will therefore no longer appear on the export certificate. If you wish to mention the production location, please indicate the company/address on the product list. The product list forms part of the export certificate and will continue to be stamped and attached.

What information belongs on a product list?

In accordance with section 4.5 of the guidance document, the following information belongs on the product list:

For each medical device:

CHRN (Swiss Single Registration Number) of the manufacturer and/or authorised representative.
Basic-UDI-DI
unique identification number of the certificate issued by the respective authority (CE certificate number)
reference or article number
Name
Class
GMDN code or other nomenclature code

The product list must be submitted in English, in PDF format, with the name and address of the company applying and with continuous page numbering. You can find an example of a product list in Figure 4.5.1 of the guidance document.

Why does the CE certificate number for each medical device now have to be indicated in the product list?

When the revised Therapeutic Products Act (revTPA) entered into force on 25 May 2021, the legal provisions for issuing export certificates and attestations were aligned with those of the European Union (MDR/IVDR).

For traceability reasons, it is necessary to indicate for each medical device the number of the relevant EC certificate(s) (depending on the class of the medical device) that cover(s) that device. You can find the risk class listing in Figure 4.6.1 of the guidance document.

Why are the product lists sent with an FSC order not allowed to contain medical devices certified according to two different laws?

Since the revision of the Swiss medical devices ordinance (MedDO and IvDO), product lists may only contain medical devices that are certified according to either the current or the old legislation. For this purpose, two different order forms are available on our website - one for medical devices according to current legislation and a second one for medical devices according to old legislation, as well as DEVIT and IVDs (in addition to the information in our guidance document from point 4 "How to obtain an export certificate").

Swissmedic confirms with the FSC certificate that the medical device(s) included in the order fall(s) under one of the above mentioned legislations.

Why is a 30-day period allowed for issuing an FSC?

Since all orders will be delivered promptly, it may be possible to shorten the delivery times if the order volume remains low. Swissmedic will leave this time limit unchanged.

How much are the fees for the issue of a FSC?

The ordinance of the Swiss Agency for Therapeutic Products on its fees specifies the following fees:

Issue of an export certificate (Art. 4, para. 1 and annex 2 GebV-Swissmedic): CHF 200 per certificate.
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, withdrawal of an order after work has already been carried out, requests for information or the correction of a certificate as a result of a mistake made by the requesting company. No fees are charged for the correction of a mistake made by Swissmedic.

Is forwarding for certification by the Federal Chancellery or a Consular Service possible?

The export certificates are delivered only to the address of the requesting company. Swissmedic will not forward them to third parties. Therefore, if you want legalization of the signature you have to send the final FSC to the Federal Chancellery and / or a Consular Service for additional legalization by the embassy or consulate in Switzerland.

Further information on legalizations can be found on the website of the Swiss Federal Chancellery.

How must replies and supplementary submissions – e.g. due to complaints regarding export certificates – be sent?

All replies and supplementary submissions regarding export certificates must be sent via Swissmedic’s eGov eMessage service. To do so, please select delivery type “Response to Swissmedic correspondence”. It is also important to state the Swissmedic reference no. (102xxxxxxx) under “Reference to original application number”.

Which deadlines apply for in case of complaints by Swissmedic?

According to para. 2.3.4 of the Service agreement for export certificates the Agency requires a processing time of 30 days from the date on which all the information and documents needed to provide the service are present. The deadline ends after the certificate has been sent to the applicant.

This means that in case of complaints the date of application submission is no longer relevant to determine the deadline for processing the application. The deadline of 30 days starts as soon as all deficiencies are rectified and all documents requested for the application are available to Swissmedic. The date of the last submission via the eGov Service eMessage (“Acceptance of Delivery”) can be used as date of reference.

Where can I find the French, English or Italian version of the two order forms (old legislation and existing legislation)?

There are no longer individual language versions for these two forms. The language can be changed by clicking on the relevant language.

Why it’s not possible to scan the application form and submit it electronically via the eGov Service eMessage?

The information contained in the application form is imported as XML format in the business case processing system of Swissmedic. Scanned application forms generate technical problems as the information contained cannot be identified and read from the system. As a consequence, these applications cannot be processed and will be rejected.

Why does a new order form from the Swissmedic website have to be downloaded and completed for each individual FSC order?

All details from an order form are transferred into the Swissmedic business case processing system via XML import.

Order forms that have already been transferred for a previous order and then amended can therefore no longer be input automatically as this generates error messages.

Why are incomplete FSC orders given 30 days to complete?

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, a completely new order will have to be sent containing the necessary information and documents, as indicated on our website.

Which supporting documents must be attached when placing an order?

In addition to the usual mandatory documents to be issued (as indicated in our guidance document), the declarations of conformity and certificates to be attached depending on the class of medical device are listed in our guidance document, in section 4.6 et seq. With regard to the validity of certain certificates, please pay particular attention to our publication “Information sheet obligations economic operators CH”. A copy of the confirmation letter issued by the notified body must also be sent to us (source The European Association for Medical devices of Notified Bodies).

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

Adaptation of the ordering process from 01.01.2023

Forms and instructions