Exporting Unapproved Medical Devices

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Exporting Medical Devices | FDA

https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices

Establishments exporting devices from the United States (U.S.) are often asked by foreign customers or foreign governments to supply proof of the devices’ regulatory or marketing status as regulated by the Food and Drug Administration (FDA). The Export Reform and Enhancement Act of 1996 authorized the … See more

PMA Import/Export | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/premarket-approval-pma/pma-importexport

Export of Approved PMA Devices Requirements Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. …

FDA'S NEW APPROACH TO EXPORT REGULATION

https://www.mddionline.com/news/fdas-new-approach-export-regulation

EXPORT OF INVESTIGATIONAL DEVICES The Export Reform Act states that any investigational device intended for export to one of the listed countries may be …

Expanded Access to Unapproved Medical Devices - UCI …

https://research.uci.edu/human-research-protections/clinical-research/devices-used-in-clinical-research/expanded-access-to-unapproved-medical-devices/

Unapproved medical device is a device that is utilized for a purpose, condition, or use for which the device requires, but does not have, an approved application for premarket …

Private Import with Doctor's license of unapproved …

https://www.j-mdc.com/en/import/index.php

A medical doctor or dentist can import unapproved devices by presenting his/her doctor’s license. This is limited to cases where there is a clinical urgency and …

Importing Medical Devices Into The US: What You Need …

https://usacustomsclearance.com/process/importing-medical-devices-into-the-us/

Foreign exporter of devices Manufacturer Component Manufacturer; There are some exceptions to this Remanufacturer Regardless, it’s worthwhile to verify whether or not you’re required to …

Magnolia Medical Technologies I Makers of Steripath®

https://magnolia-medical.com/

The Steripath® Initial Diversion Device® is the only FDA 510(k)-cleared device platform specifically indicated to reduce blood culture contamination 3 for sepsis testing accuracy. …

Importing & supplying medical devices | Therapeutic …

https://www.tga.gov.au/resources/resource/guidance/importing-supplying-medical-devices

Information for health professionals Last updated 3 January 2023 Listen On this page: Regulation | Importing medical devices | Health professionals as sponsors | …

Class Action Lawsuit List | Open & Current Cases

https://www.classaction.org/list-of-lawsuits

Attorneys have filed a proposed class action lawsuit alleging that Philips knew well before the recall about the risks associated with these devices and that consumers are now on …

Regulatory requirements for importing medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html

destined for export sale Who can import An importer is any person in Canada, other than the manufacturer of a medical device, who is responsible for the medical device coming …

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