Medical Device Establishment Registration: FDA has divided into two groups of establishments which is domestic and foreign establishments. In general, if you are a manufacturer of medical device must register and list the device. However, except for initial importer do not need to register but also the companies require listing device to the FDA.

The initial importer is who responsible for furthers the marketing of a device from a foreign manufacturer to the final distributor for sale device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.