The U.S. Department of the Treasury and the Internal Revenue Service (IRS) recently issued final regulations under Section 4191 of the Internal Revenue Code (Code), which imposes a 2.3% tax on sales of any “taxable medical device” by a manufacturer, producer or importer.
What is a “taxable medical device?”
The Code defines a “taxable medical device” as any “device” under the Federal Food Drug and Cosmetics Act (FFDCA) that is intended for humans. Attempting to provide greater certainty, the final regulations provide that if a product is required to be registered and listed with the Food and Drug Administration pursuant to Section 510(i) of the FFDCA and 21 C.F.R. part 807, it is a taxable medical device. Classification as a taxable medical device does not take into account actual use of a product or any policy considerations. For example, dual-use devices are taxable medical devices whether or not they are used for a medical purpose, and Humanitarian Use Devices (as defined in Section 201(h) of the FFDCA) are not exempt.
It is assumed most manufacturers will add this tax to the price of their goods and pass it on unnoticed simply by including it in their selling price. We do not believe this is fair to our customers, so the 2.3% tax will be clearly listed on all applicable sales orders.
Salt Lake City — December 21, 2012 — JTECH Medical again received the renewal of their ISO 9001:2008 and ISO 13485:2003 with Canadian Medical Devices Conformity Assessment System (CMDCAS) certifications for its manufacturing facility - continuing its commitment to excellence in quality.
“These certifications are an endorsement of JTECH’s USA-based manufacturing capabilities and dedication to quality management systems,” says JTECH Medical President, Len Smith. “JTECH has a tradition of regulatory compliance which ensures clinicians they are utilizing world-class medical devices.”
The ISO 9001:2008 and ISO 13485:2003 with CMDCAS standards has specific requirements the quality management system of an organization has to meet, such as consistently providing products that meet customer and applicable statutory and regulatory requirements. It also aims to enhance customer contentment through the effective application of the system, including processes for continual enhancement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. The ISO standards provide a tried and tested framework for taking a methodical approach to managing an organization's processes so that it consistently turns out products that satisfy customer expectations and can assure regulatory authorities that JTECH Medical is manufacturing products using a quality management system in its facility.
JTECH Medical is a world leader in physical evaluation, functional assessment and functional testing products. Technological innovation is a directive at JTECH Medical. The in-house programming and engineering staff developed and patented the world’s first digital dual inclinometer and introduced computerized functional testing to medical practices before computers were standard equipment. Today customers enjoy the ability to test how and where they want with a radio frequency based wireless evaluation system, which includes important technical features such as frequency hopping and bidirectional data verification giving assurance that data is accurate and reliable.
Companies' compliance to ISO standards are certified by third-party audit and registration organizations, such as Intertek. For more information, visit http://www.intertek.com.
Below is a list of JTECH's Certifications:
ISO 13485:2003 CMDCAS Certificate
ISO 9001:2008 Certificate
Canadian Medical Device Establishment License
Canadian Medical Device License for Kits
Canadian Medical Device License for Physical Evaluation and Testing Products
Canadian Medical Device License for Software
JTECH completed testing and validation of our software with the Windows 8 operating system. Updates will be posted to this site and our Customer Portal as they become available.