Medical Device Registered Importers Identified by Manufacturers

$179 / 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

2019-04-08

Version

2019-04-08

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

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

NameDescriptionTypeConstraints
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
16373858818114
16226707802712
17839077647543
19335929477543
20643374347543
15361263787543
19688400817543
15987484037543
17767593927543
17837319277543