(a) Imposition of tax. Under section 4191(a), tax is imposed on the sale of any taxable medical device by the manufacturer, producer, or importer of the device. For the definition of the term taxable medical device, see Sec. 48.4191-2.
(b) Rate of tax. Tax is imposed on the sale of a taxable medical device at the rate of 2.3 percent of the price for which the device is sold. For the definition of the term price, see section 4216 and Sec. Sec. 48.4216(a)-1 through 48.4216(e)-3.
(c) Liability for tax. The manufacturer, producer, or importer making the sale of a taxable medical device is liable for the tax imposed by section 4191(a). For rules relating to the determination of who the manufacturer, producer, or importer is for purposes of section 4191, see Sec. 48.0-2(a)(4). For the definition of the term sale, see Sec. 48.0-2(a)(5). For rules relating to the lease of an article by the manufacturer, producer, or importer, see section 4217 and Sec. 48.4217-1 through Sec. 48.4217-2. For rules relating to the use of an article by the manufacturer, producer, or importer, see section 4218 and Sec. 48.4218-1 through Sec. 48.4218-5.
(d) Procedural rules. For the procedural rules relating to section 4191, see part 40 of this chapter.
(e) Tax-free sales for further manufacture or export. For rules relating to tax-free sales of taxable medical devices for further manufacture or export, see section 4221 and Sec. 48.4221-1 through Sec. 48.4221-3.
(f) Payments made on or after January 1, 2013, pursuant to lease, installment sale, or sale on credit contracts. For rules relating to the taxability of payments made on or after January 1, 2013, pursuant to a lease, installment sale, or sale on credit contract entered into on or after March 30, 2010, see Sec. 48.4216(c)-1(e)(1). For rules relating to the taxability of payments made on or after January 1, 2013, pursuant to a lease, installment sale, or sale on credit contract entered into before March 30, 2010, see Sec. 48.4216(c)-1(e)(2).
(g) Effective/applicability date. This section applies to sales of taxable medical devices on and after January 1, 2013. [T.D. 9604, 77 FR 72934, Dec. 7, 2012]