Practical Guide to the Classification of Medical Devices in the U.S.
This White Paper is a concise and practical guide to theclassification of Medical Devices in the United States, with afocus on marketing procedures. With the help of usefulinfographics and links, it will accompany you in determining theproduct risk class and the planning required to successfullyenter the U.S. market.
1.INTRODUCTION
The classification of a medical device and the country in which it is intended to be marketed determine the regulatory pathway and documentation requirements for obtaining a marketing authorisation. This guide helps classify medical devices and determine the regulatory procedures for marketing in the United States. […]
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