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GlobalCompliancePanel, United States
2012-03-14
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.
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 abroad 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
Who will 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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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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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. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, GxP compliance, auditing, interfacing with the regulatory agencies, managing enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a well-known CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an accomplished industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background.
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Deadline for Abstracts:
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2012-03-14
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Registration:
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Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407 Fax: 302-288-6884
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E-mail:
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webinars@globalcompliancepanel.com
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