For the export of CE-marked medical devices and in vitro diagnostic medical devices to countries outside the European Union, a certificate of free sale (CFS) may be required. These certificates are issued by the Federal Office for Safety in Health Care (BASG) upon request by the manufacturer or authorised representative, provided that the requirements of Art. 60 of Regulation (EU) 2017/745 on medical devices (MDR) or Art. 55 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) are met.

It is also possible to apply for certificates of free sale for “Directive devices” (Directive CFSs – not in accordance with Art. 60 MDR / Art. 55 IVDR), provided that the conditions of the transitional provisions under Art. 120 MDR or Art. 110 IVDR are fulfilled (according supporting documents must be included with the application).

Please note:

• A CFS (formerly FSC) can only be requested by the manufacturer or the authorised representative based in Austria.
   
• A request may include a maximum of 500 products.
  If CFS are required for more products, these must be split across several requests.
   
• Certificates of free sale are issued by the BASG strictly in accordance with the wording recorded in the business register and are valid for a maximum period of two years.
   
• Copies of previously issued CFS cannot be provided. A new request must be submitted.
   
• CFS must be requested separately for each specific regulatory matter.
   
  • For “Regulation devices”, a separate request must be submitted for MDR devices and IVDR devices respectively.
     
  • For “Directive devices”, placed on the market pursuant to Art. 120 MDR (Directive 93/42/EEC concerning medical devices, or Directive 90/385/EEC concerning active implantable medical devices) and Art. 110 IVDR (Directive 98/79/EC concerning in vitro diagnostic medical devices) a separate request must be submitted .
    
     
• In addition to the documents required for requests involving “Regulation devices,” the following documents must be submitted for CFS requests for “Directive devices” :
   
  • Medical Devices
    • a) Manufacturer’s Declaration
      A self-declaration by the manufacturer confirming that the conditions for applying the transitional provisions are fulfilled for the respective devices.
      (templates are provided by industry associations)
       
    • b) Proof of a Quality Management (QM) System
      Evidence that a QM system in accordance with Art. 10 Para. 9 MDR has been implemented for the respective devices.
       
    • c) Confirmation Letter
      A letter confirming the existence of a written agreement with a Notified Body in accordance with Annex VII Section 4.3 Subparagraph 2 MDR including a list of all covered devices (device and trade name, device code, catalogue number, or another unique reference enabling identification and traceability of the device covered by the agreement. Except for the device or trade name, the Basic UDI-DI may be used for the information required for traceability of the device).
      Alternatively, the signed agreement itself may be submitted, provided it clearly identifies the covered devices (previously mentioned required information of the devices).
       
  • In vitro diagnostic medical devices (IVDs)
     
    • a) Manufacturer’s Declaration
      A self-declaration by the manufacturer confirming that the conditions for applying the transitional provisions are fulfilled for the respective devices.
      (templates are provided by industry associations)
       
    • b) Proof of a Quality Management (QM) System
      Evidence that a QM system in accordance with Art. 10 Para. 8 IVDR has been implemented for the respective devices.
      
      If available:
       
    • c) IVDR Application Submitted to a Notified Body
      An application submitted to a Notified Body in accordance with Annex VII Section 4.3 Subparagraph 1 IVDR including a list of all covered devices (device and trade name, device code, catalogue number, or another unique reference enabling identification and traceability of the device covered by the agreement. Except for the device or trade name, the Basic UDI-DI may be used for the information required for traceability of the device).
       
    • d) Confirmation Letter
      A letter confirming the existence of a written agreement with a Notified Body in accordance with Annex VII Section 4.3 Subparagraph 2 IVDR including a list of all covered devices (as described above).
      Alternatively, the signed agreement itself may be submitted, provided it clearly identifies the covered devices (previously mentioned required information of the devices).
      
      Important: If documents under points c) and d) are not yet available, the CFS can only be issued with a shortened validity period, limited to the respective transitional deadline.
       
  • Systems and procedure packs (SPP)
    A CFS cannot be issued for SPPs.
    
    Where necessary, the BASG may issue an official confirmation, subject to a fee, to clarify the circumstances for submission to the competent authority in the third country.

The request for CFSs is subject to fees in accordance with the BASG Fee Regulation under the GESG (Health and Food Safety Act, BGBl. Nr. 63/2002, as amended).

Fees are incurred at the time the request is submitted. This also applies to each identical CFS requested simultaneously.
Important: If you are unsure about the required documents (concerning the formal procedure for submitting requests – no substantive content issues), you can send your questions by email to cfs@basg.gv.at  before submitting your request.

Fees are charged regardless of whether the request ultimately results in the issuance of an CFS, including in cases where the request is withdrawn by the applicant or rejected or dismissed by an official decision.

Withdrawal of a request

In accordance with Art. 13 Para. 7 of the General Administrative Procedure Act 1991 (AVG), BGBl. Nr. 51/1991, as amended, a request may be withdrawn by the applicant at any time during the administrative procedure.

However, depending on the stage of the procedure at the time of withdrawal, the request must be subject to the appropriate fees.

• If the withdrawal takes place before all documents required for the substantive assessment of the request have been submitted, 10% of the initial fees shall be charged.
• If the withdrawal occurs at a later stage in the procedure, the request has to be charged in full by the BASG.

Changes after submission

Changes that alter the nature of the request are not permitted after submission.

Therefore, adding or replacing devices in the device list or adding further countries is not possible within a submitted request.

Allowed changes:

• Reduction of the number of devices
• Replacement or removal of countries

A reduction in the scope of the request does not reduce the fee. Fees are based on the originally submitted scope.
 

Rejection of a request

In the case of a formal rejection, 10% of the applicable fee will be charged. Rejection occurs in the following cases:

Lack of eligibility of the request:

• If the manufacturer or authorised representative is not based in Austria.

Use of the wrong request form:

• The request concerns cosmetics, food supplements, food, etc.

Incomplete request:

• If essential documents are missing, the applicant will receive a request for improvement under Art. 13 Para. 3 AVG.
• If the missing documents are not submitted within the given timeframe, the request will be formally rejected.
   

Dismissal of a request

If the request is dismissed by decision, the full fee is charged. This occurs when:

Non-compliance:

• If non-compliances are identified during the substantive assessment of a request, the applicant will be given the opportunity to comment, by means of a party hearing in accordance with Art. 45 Para. 3 AVG and will be requested to resolve these non-compliances within a reasonable period of time.
• If the non-conpliances are not fully resolved within the deadline, the request has to be dismissed by BASG.

• Step 1: Read instructions  for requesting a CFS and download the current version of documents
• Step 2: Fill in or update the overview list of documents (Directive or Regulation)
• Step 3: Create device list (devices requested for) in the document overview list. Please use a copy of the template worksheet tab, as it contains the required headers and footers necessary for issuing the CFS.
• Step 4: Fill in new request form
• Step 5: Send the request form, document overview list and documents to: cfs@basg.gv.at
• Please format the subject line of the email as follows:
  CFS country or countries (or, for multiple CFSs: number of CFSs), company, number of devices, Directive or Regulation
  Examples:
  • CFS Taiwan, Example GmbH, 54 devices, Directive
  • 10 CFSs, Example GmbH, 79 devices, Regulation

Please note:

When requesting certificates of free sale, the current version of the request form (request form) must be used.

If this is a subsequent application, always use the current version of the overview list of documents. For the assessment, all required documentation must be submitted for each requested product (for further information, please refer to the instructions on requesting a CFS).

The documents must in general be submitted in German.

1. For "professional use only" devices (use is reserved exclusively for professional users) information can be provided in English or German
2. If the device is not placed on the market in Austria, English documents are sufficient

Requested CFS are created in accordance with the device list created by the manufacturer in the overview list of documents. Accordingly, changes in the Excel sheet in the “overview of documents” must always be transferred to the device list. 

Issued certificates of free sale will be sent exclusively to the applicant. 
Applicants must obtain the additional certification from the BMEIA themselves at the Office for Consular Legalisations (contact for legalisation – BMEIA – Ministry of Foreign Affairs of Austria). 

For the sake of completeness, the BASG points out that request will be processed in the order in which they are received. The time from the request submission to the completion of the processing of a request cannot be predicted, as this depends both on the fluctuating volume of requests and on the quality and completeness of the individual requests.

The AVG generally provides for a decision period of 6 months. These decision deadlines will be suspended by any subsequent submissions. 

• Instructions for requesting issuance of a CFS
• Documents-Overview Directive Devices
• Documents-Overview Regulation Devices
• Request form

Links

• Fee regulation (section XIII)

You can find an overview of common deficiencies in CFS request via this link: Common deficiencies