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Medical Device Approval & Regulation in 16 Countries: Brief Overviews

Medical Device Approval & Regulation in 16 Countries: Brief Overviews

9781634842426
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Description
This book describes the approval process for medical devices in the European Union and fifteen countries, and also indicates whether or not an expedited approval procedure is available. Many of the countries reference EU law, including France, Germany, the Netherlands, and Switzerland. Israel more readily approves devices with a CE mark (indicating approval in the EU) or an indication that they are approved by the US Food and Drug Administration (FDA). In many nations, particularly those influenced by the EU, part of the review process is conducted not by the government but by private, independent organisations called notified bodies. Furthermore, this book provides a description of FDAs medical device review process divided into two parts:: premarket requirements and post-market requirements.
Product Details
75099
9781634842426
9781634842426

Data sheet

Publication date
2016
Issue number
1
Cover
paperback
Pages count
57
Dimensions (mm)
155.00 x 230.00
Weight (g)
144
  • Preface; Approval of Medical Devices:: European Union, Australia, Brazil, Canada, China, France, Germany, Israel, Japan, Mexico, Netherlands, Russian Federation, South Africa, Spain, Switzerland, United Kingdom; FDA Regulation of Medical Devices; Index.
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