Medical devices imported into United States need to comply with FDA regulations.<\/p>\n
Prototypes for testing purposes<\/strong> do not need FDA registration. \u00a0When entering the United States, they need to be cleared by FDA before distribution for testing. \u00a0FDA may need a letter explicitly stating these products are testing prototypes not sold to the general public.<\/p>\n Devices sold to the general public<\/strong> require FDA registration by both the manufacturer and the importer. \u00a0Registrations fees<\/a> are also required. \u00a0The following better illustrates the type of establishments who must register for their medical devices and also the most recent changes to the registration and listing requirements:\u00a0Click here<\/a>.<\/p>\n 510K Pre-market notification\u00a0<\/strong>may also be a requirement and is at the discretion of FDA. \u00a0Click here<\/a> for more information.<\/p>\n