Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
May 12, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
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. Areas Covered in the Session: 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 Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1bM6SeE support@compliance4all.com www.compliance4all.com