This document provides an overview of the requirements for importing and exporting medical devices. Any medical device legally in the US can be exported without FDA approval, but devices not approved in the US must follow export provisions. Foreign manufacturers importing devices into the US must comply with FDA regulations. Imported devices must also meet Customs requirements and may be detained if noncompliant. The webinar will cover import/export requirements, regulations, entry documentation, and exporting approved and unapproved devices. It is intended to benefit those in regulatory, clinical, quality, marketing, and other roles involved in imports and exports.

1. Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements- Online
Compliance Panel
Description:
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA
notification or approval. The export provisions under section 802 of the FD&C Act only apply to
unapproved devices.
Devices that have not been approved or cleared in the U.S. must follow the export provisions of the
FD&C Act. 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. All medical devices that are imported into the U.S. must meet
Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not
meet FDA regulatory requirements may be detained upon entry. This Webinar will provide a broad
overview of the requirements and expectations and an introduction to the regulations, including 21 CFR
1, Subpart E--Imports and Exports. Entry information should identify the product and include
appropriate information to demonstrate that the product is in compliance with FDA regulations. Product
information should include device name and product code.
The affirmation of compliance should include: importer registration number, foreign establishment
registration number and name of U.S. agent, medical device listing number, and Premarket Notification
510(k) or Premarket Approval number, if applicable. For exporting, while FDA does not place any
restrictions on the export of devices, certain countries may require written certification that a firm or its
devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing
a Certificate for Foreign Government (CFG). Learn the process for unapproved and approved medical
devices to be exported and the documentation process involved.
Objectives of the Presentation:
Examine the import and export requirements for medical devices
Introduction to FDA references and guidance documents related to import and export requirements
Understand the regulatory process if you are a foreign manufacturer or initial importer and want to sell
your device in the U.S.
Import Alerts
Recordkeeping requirements and your responsibilities
How to export unapproved and approved medical devices

2. Who can Benefit:
This webinar will provide valuable assistance and guidance to device companies involved in importing
and exporting of medical devices. Employees who will benefit include:
All levels of management and departmental representatives and those who desire a better
understanding or a "refresh" overview of the export/import process
Regulatory Affairs
Clinical Affairs
Quality and Compliance
Marketing & Sales
Distributors/Authorized Representatives
Engineering/Technical Services/Operations
Consultants
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