Open AccessOverview of the Regulation of Medical Devices and Drugs in the European Union and the United States
Author(s) -
Fiona Masterson,
Kathryn Cormican
Publication year - 2013
Publication title -
therapeutic innovation and regulatory science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.569
H-Index - 44
eISSN - 2168-4804
pISSN - 2168-4790
DOI - 10.1177/2168479013500969
Subject(s) - european union , pharmacy , process (computing) , business , medical device , political science , pharmacology , medicine , risk analysis (engineering) , international trade , computer science , law , biomedical engineering , operating system
This article provides an overview of the regulation of medical devices and drugs in the European Union and the US. It is important for all stakeholders involved in bringing a medical device or drugs to market to have an understanding of the regulatory requirements involved in this process. This article demonstrates that the regulation of these products is an extremely complex process.
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