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Asian Institute of Research, Journal Publication, Journal Academics, Education Journal, Asian Institute
Asian Institute of Research, Journal Publication, Journal Academics, Education Journal, Asian Institute

Economics and Business

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ISSN 2775-9237 (Online)

asian institute research, jeb, journal of economics and business, economics journal, accunting journal, business journal, managemet journal
asian institute research, jeb, journal of economics and business, economics journal, accunting journal, business journal, managemet journal
asian institute research, jeb, journal of economics and business, economics journal, accunting journal, business journal, managemet journal
asian institute research, jeb, journal of economics and business, economics journal, accunting journal, business journal, managemet journal
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open access

Published: 25 November 2023

Regulation of Medical Devices – A Poland and U.S. Study: Marketing and Legal Aspects

Richard J. Hunter, Jr., Héctor R. Lozada, John H. Shannon, Gary H. Kritz

Seton Hall University, University of Tulsa

asian institute research, jeb, journal of economics and business, economics journal, accunting journal, business journal, management journal

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doi

10.31014/aior.1992.06.04.546

Pages: 177-199

Keywords: Medical Devices, Foreign Direct Investment, Field Service Corrective Actions, Advertising, Conformity, Food and Drug Administration

Abstract

Consider this scenario: One of your former students working in the medical devices field for over twenty years has been approached by a medical device manufacturer in Poland who wishes to market its medical devices in the European Union and eventually expand into the United States. You learn that the Polish government is especially interested in pursuing this opportunity as part of its larger outward foreign direct investment strategy. Your student is being considered as the CEO of prospective U.S. operations. Part I is a study of the various issues that will confront the potential Polish exporter in meeting European Union standards which will guarantee compliance with EU Regulation (EU) 2017/745 on medical devices (MDR). Part II discusses U.S. regulations concerning the importation of medical devices into the United States and the advertising & labeling of such devices.

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