Medical Device Manufacturers Identified by Importers

$79 / year

This dataset shows foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. In order to import medical devices and/or products that emit radiation into the U.S., the product must meet FDA regulatory requirements. Food and Drug Administration (FDA) does not recognize regulatory approvals from other countries. The following is a summary of FDA requirements for medical devices and products that emit radiation.

Complexity

Medical Device Manufacturers Identified by Importers dataset contains details of Medical Device Manufacturers including Manufacturer registration key. Foreign 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

Medical Device Manufacturers, MD Manufacturers, Medical Device Importers

Other Titles

Medical Device Manufacturers, MD Manufacturers Identified by Importers

Name Description Type Constraints
Importer_Manufacturer_IdThe importer manufacturer IDintegerrequired : 1 level : Nominal
Registration_KeyThe Registration Keyintegerrequired : 1 level : Nominal
Manufacturer_Registration_KeyMedical device manufacturer registration keyintegerrequired : 1 level : Nominal
Registration_Key_ValueKey value related to Registration Listing ID of the Establishmentintegerrequired : 1 level : Nominal
Importer_Manufacturer_IdRegistration_KeyManufacturer_Registration_KeyRegistration_Key_Value
49566726751078594457
17129412941175148088
16879087901302882552
666327437441082791065
666337437441514377823
356381307441082791065
290615528421255399877
290515528421873238686
290815575751644399270
880908590862032970658