Overview
The United States (U.S.) Food and Drug Administration (FDA) is responsible for ensuring that medical devices (including in vitro diagnostics) and radiation-emitting electronic products comply with applicable U.S. regulations when offered for importation into the United States. Foreign establishments must comply with these applicable regulations before, during, and after the medical device or radiation-emitting electronic product is imported into the United States or territory. FDA does not recognize regulatory authorizations from other countries. The product must meet the applicable FDA regulation.
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.
FOREIGN MANUFACUTERERS OF MEDICAL DEVICES
A foreign manufacturer is a manufacturer located outside of the United States. Foreign manufacturers must meet applicable U.S. regulations in order to import a device into the U.S.
The basic regulatory requirements include:
Establishment registration
Medical Device Listing
Quality System
Premarket Notification [510(k)], unless exempt, or Premarket Approval
Labeling
Medical Device Reporting. Read More→
