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ARTICLE · 19 DECEMBER 2012

IRS Finalizes Rules For Medical Device Excise Tax

The IRS has finalized its regulations on the medical device excise tax and released interim guidance that provides safe harbor rules for determining constructive sales price.

United StatesTax

The IRS has finalized its regulations on the medical device excise tax and released interim guidance that provides safe harbor rules for determining constructive sales price. Beginning on Jan. 1, 2013, manufacturers, producers and importers are required to remit a 2.3% manufacturers excise tax levied on the sale of medical devices. There are exceptions for devices sold for further manufacture or export, and devices that are generally purchased by the public at retail for individual use.

The final regulations (TD 9604) and interim guidance (Notice 2012-77) make very few changes to the facts-and-circumstances test and safe harbor for the retail exception, but do clarify several important points, including:

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