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Global Regulatory Requirements for Medical Devices

<p>Medical devices are becoming more important in the health care sector. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union.</p><p>The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. A company goes far by following the requirements in EU, USA or the GHTF guidelines.</p>

Identiferoai:union.ndltd.org:UPSALLA/oai:DiVA.org:mdh-700
Date January 2008
CreatorsBrolin, Sandra
PublisherMälardalen University, School of Sustainable Development of Society and Technology, Akademin för hållbar samhälls- och teknikutveckling
Source SetsDiVA Archive at Upsalla University
LanguageEnglish
Detected LanguageEnglish
TypeStudent thesis, text

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