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The EU Import Requirements For Medical Devices By Comparison With The USA And The GHTF Guidelines

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Executive Summary

Medical devices and supply companies are under enormous pressure to fulfill trade requirements dictated by current global markets, especially by the EU, although it is largely recognized that the innovative medical devices and procedures can considerably improve diagnostics and shorten therapeutic cycles. There are more than 8000 generic medical device groups where some devices contain drugs. The EU increases the demand for better regulatory frameworks to ensure that products entering the market are safe and efficient, even if they are essential for people's health and quality of life, and the industry that provides them plays a significant role in the economy.

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