Medical Device Approval & Regulation in 16 Countries

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 FDA's medical device review process divided into two parts: premarket requirements and post-market requirements.