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Approval of Medical Devices in Various Countries
Global Legal Research Directorate (au)
This report describes the approval process for medical devices in the European Union (EU) and 15 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 U.S. 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 organizations called šůžnotified bodies,šůĚ which are designated by EU Member States. In most of the countries in the survey, medical devices are categorized based on the risks associated with their use, and the approval process varies by category. This is a print on demand report.
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