Import and Export of Medical Devices

 

The Import and Export of Medical Devices industry is an attractive sector despite of many challenges. Any medical device, including a radiation-emitting electronic product that is also a medical device may be exported from the United States to anywhere in the world without prior FDA notification or approval to export, if it can be legally marketed in the United States.Import and Export of Medical Devices intended is subject to the provision of the Medical Device Amendment and other provisions of the Federal Food, Drug and Cosmetics Act. There are number of ways in which treatment of Import and Export of Medical Devices vary.

Import and Export of Medical Devices 

Export of Medical Devices: Exporting Medical 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 FDA to issue an export certificate and charge a fee for each certification that is issued within 20 working days. An export certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status in the United States (U.S.).

Import of Medical Devices: FDA verifies and enforces applicable medical device requirements at the time a medical device is imported or offered for import into the United States. FDA’s Center for Devices and Radiological Health (CDRH) is responsible for overseeing the medical device program.Under the MDR regulations, an importer is required to report incidents in which a device may have caused or contributed to a death or serious injury as well as certain malfunctions.

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