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Austria announces a new medical device tax which must be paid by June 2012 covering the year 2011

Austria is introducing a new tax system on medical devices which must be paid for the first time by June 2012 for the year 2011. This tax payment is used by the Austrian Competent Authority (Austrian Federal Office for Safety in Health Care) to monitor the medical devices market and carry out its national vigilance (read: enforcement) responsibilities.

It will be a single annual fee which must be paid by any person or organization who delivers a medical device to a final consumer (or end user) in return for payment. This includes renting or leasing of medical devices.

The tax rate is based on risk classification as follows in Euros:

    Risk Class 1 medical devices, €250 (Approx. US$355)
    Risk Class IIa medical devices and self-testing IVDs, €300 (Approx. US$413)
    Risk Class IIb medical devices and IVDs in Annex II list B, €350 (Approx. US$482)
    Risk Class III medical devices, IVD;s in Annex II list A: Active implantable medical devices, €400 (Approx. US$550).

Companies supplying multiple risk classification of devices will only need to pay the highest tax and not a total of all the taxes together.

Larger companies with several establishments will only have to pay a maximum of €2,000 (Approx. US$2,753) in total.

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