System for issuing Export Certificates (FSC) for medical devices – Questions and answers

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.

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.

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.

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.

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.

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.

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.

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”.

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. 

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

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.

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.

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.

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).