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Clinical Evaluation of Medical Devices: How to Negotiate the Maze of Regulations Around the World

When it comes to medical devices not only is the regulatory environment around the world rather confusing, in a number of countries the regulation for medical devices is only being established and difficult to come by. In this paper we will review the different regulatory environments in Europe, the USA and Japan, as well as in selected emerging markets, such as India, China or Brazil, with a focus on clinical evaluation and investigation.