DeutschEnglish

Certificate of free sale

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 authorized representative, provided that the requirements of Article 60 of Regulation (EU) 2017/745 on medical devices (MDR) or Article 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.
  • Certificates of free sale issued by the BASG are valid for a maximum of 2 years.
  • Copies of previously issued CFS cannot be provided. A new request must be submitted.

  • Each request may only include either “Directive devices” (Directive 93/42/EEC on medical devices, Directive 98/79/EC on in vitro diagnostic medical devices, Directive 90/385/EEC on active implantable medical devices) or “Regulation devices” (MDR, IVDR), not both.

     

  • Additional documentation required for CFS requests for “Directive devices”
    In addition to the documents required for requests involving “Regulation devices,” the following documents must be submitted 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 (product and trade name, product code, catalogue number, or another unique reference enabling identification and traceability of the device covered by the agreement. Except for the product 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 (product and trade name, product code, catalogue number, or another unique reference enabling identification and traceability of the device covered by the agreement. Except for the product 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)
    For SPPs that include (even partially) “Regulation devices,” a CFS cannot be issued.

    For SPPs composed exclusively of “Directive devices,” a CFS may be issued, provided that all conditions outlined in the MDCG 2022-25 Rev. 1 guidance document (under the heading “Systems and procedure packs”, page 7) are fully met.
     

Fee for requests for the issuance of CFS

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 documentation, please contact us via email at fsc@basg.gv.at  before submitting your request.

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regardless of whether therequest ultimately results in the issuance of an CFS, including in cases where the request is withdrawn by the applicant or rejected by an official decision.

 

Withdrawal of a request

According to 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.

  • If the withdrawal occurs before all documents required for substantive review have been submitted, 10% of the original fee is charged.
  • If the withdrawal occurs at a later stage, the full fee is due.
     

Changes after submission

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

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

Allowed changes:

  • Reduction of the number of products
  • 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:
    For example, if the manufacturer or EC-REP is not based in Austria, or if 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:

  • During the substantive review, non-conformities are identified.
    The applicant is given the opportunity to respond under Art. 45 Para. 3 AVG.

    If the non-conformities are not fully resolved within the deadline, the request will be dismissed.
     

Request - Procedure

  • Step 1: Read instructions
  • Step 2: Fill in or update the overview list of documents
  • Step 3: Create product list (products 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 request form
  • Step 5: Send the request form, document overview list and documents to: fsc@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 products, Directive or Regulation
    Examples:


    i. CFS Taiwan, Example GmbH, 54 devices, Directive
    ii. 10 CFSs, Example GmbH, 79 devices, Regulation
     

Documents & Forms

 

Links

Email

Further inquiry note

fsc@basg.gv.at