Medical Device Registered Importers Identified by Manufacturers

$79 / year

This dataset contains details of Medical Device Importers. Establishments that are required to register with the Food and Drug Administration (FDA) are also required to list the devices that are made there and the activities that are performed on those devices.

Complexity

Manufacturers must meet applicable United States (U..S.) medical device regulations in order to import devices into the U.S. even if the product is authorized for marketing in another country. These requirements include registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation, medical device reporting of adverse events, and Premarket Notification 510(k) or Premarket Approval, if applicable. In addition, the foreign manufacturers must designate a United States agent. As with domestic manufacturers, foreign manufacturing sites are subject to FDA inspection. Information on U.S. regulatory requirements can be found in the Device Advice section.

Date Created

2013

Last Modified

2018-07-16

Version

2018-07-16

Update Frequency

Weekly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs => U.S. Food and Drug Administration (FDA)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Registered Importers, Medical Device Importers, MD Identified Manufacturers

Other Titles

Medical Device Registered Importers, MD Registered Importers, MD Registered Importers Identified by Manufacturers

Name Description Type Constraints
Registration_Key_ValueKey value related to registration listing ID of the establishmentintegerrequired : 1 level : Nominal
Importer_Registration_KeyThe medical device importer registration keyintegerrequired : 1 level : Nominal
Establishment_Registration_KeyThe establishment registration keyintegerlevel : Nominal
Registration_Key_ValueImporter_Registration_KeyEstablishment_Registration_Key
20245258231716
15494060051716
13582732631716
13992883441716
17905428251716
16251978041716
19686637301716
10454727431716
13503682441716
14240516561716