Live Webinar
on
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
Date & Time: Thursday, March 08, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: David R. Dills
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview: 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 applies 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.
Areas Covered in the Session: l
Examine the import and export requirements for medical devices
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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
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the U.S. Import Alerts Recordkeeping requirements and your responsibilities How to export unapproved and approved medical devices
Click here to register for this webinar Who Will Benefit: l
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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
David R. Dills Industry Regulatory & Compliance Consultant David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. ...more
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