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IRS Releases Proposed Regulations on Medical Device Excise Tax

Guidance impacts manufacturers, producers and importers of medical devices


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On February 7, 2012, the U.S. Treasury Department issued Proposed Regulations under Treasury Regulations §48.4191 which provide guidance for the medical device excise tax (“MDET”) that was enacted as part of the Health Care and Education Reconciliation Act of 2010, in conjunction with the Patient Protection and Affordable Care Act. Effective January 1, 2013, IRC §4191 imposes a 2.3% excise tax on sales of certain medical devices by the manufacturer, producer, or importer of the device. The proposed regulations provide guidance on the types of devices that are subject to the tax, provide clarification on the retail and other exemptions and leverage the existing manufacturing excise tax regulations.

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