Free Sale Certificate - (FSC)

A certificate of free sale may be required for the export of CE marked medical devices and in vitro diagnostics outside the common market.

Please note:

• Certificates of free sale (FSC) are only issued for medical devices and in vitro diagnostics.
• A certificate of free sale can only be applied for by the manufacturer or the European authorised representative based in Austria.
• The medical devices and in vitro diagnostic medical devices applied for must fulfil the legal requirements and be CE-marked.
• Within the common market, CE-marked medical devices can be marketed without official confirmation. I.e. no certificate of free sale is issued.
• Copies of already issued certificates of free sale are not available, a new application is necessary.
• Only directive products (RL 93/42/EEC, RL 98/79/EC, RL 90/385/EEC) OR regulation products (VO 2017/745, VO 2017/746) can be applied for with one application.

Application - Procedure

• Step 1: Read instructions
• Step 2: Fill in or update the overview list of documents
• Step 3: Create product list (products applied for) in the document overview list
• Step 4: Fill in the application form
• Step 5: Send the application form, the overview list of documents and the documents to: fsc@basg.gv.at

Documents & Forms

• Instructions
• Documents-Overview Directive-Products
• Documents-Overview Prescription Products
• Form: Application for Certificate of Free Sale
• Form: Application confirmation general laboratory supplies

Links

• Fee regulation XIII
• Austrian Register for Medical Devices
• EUDAMED (registration as economic operator)