In the US, the approvals for medical devices are done by the FDA. The FDA approves the device for the whole country, and has the ability to inspect and audit. In addition, they have the authority to take products off the market and even shut down companies if they find necessary. As a result, in the US, it is very difficult in getting the approval of medical devices. In the EU, the EU Regulatory and Government bodies determine the regulations for all the countries. When a device is approved in one country, then it is approved in all EU. There are the Competent Authority, Manufacturer, and Notified Body in approving the medical devices in EU. Depending on the document filled, the approval of the device is given.