This report 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 organizations called “notified bodies.” These organizations 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. For example, in the United Kingdom, manufacturers of low-risk devices may register with the government agency and simply declare that the devices meet the requirements to be approved. Devices classed as higher risk must undergo more detailed review, by a notified body.
On the question of an expedited approval process, Australia, Canada, China, Japan, Spain, and Switzerland permit some sort of rapid review in particular cases, often when a device is required for an individual patient and no substitute is available. Mexico has provided for more rapid approval of devices if they have already been approved in either Canada or the United States. No such procedure exists at present in Brazil, France, Israel, the Russian Federation, or the United Kingdom. The Russian Federation did have a rapid approval system in place prior to August 2014. Germany provides for temporary approval of devices in limited circumstances. South Africa is now considering draft legislation that would include expedited procedures in specified situations.
Full Report (PDF, 2.29MB)
Global Legal Research Directorate Staff
Last Updated: 06/09/2015