Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

    /David R  /Dillsspeaker of compliance global
    Speaker: David R Dills
    Duration: 60 Minutes
    Product Code: 700235
    Level: Beginner
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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. customs 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 rules & regulations may be detained upon entry.

why should you attend

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.

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Areas Covered

  • Examine the import and export requirements for Medical Devices
  • Introduction to FDA references and guidance documents related to import and export requirements

Learning Objectives

  • 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

  • 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 Personnel
  • Clinical Affairs Personnel
  • Quality and Compliance Professionals
  • Marketing and Sales Professionals 
  • Distributors/Authorized Representatives
  • Engineering/Technical Services/Operations Personnel
  • Consultants

SPEAKER

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape.

Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives.

Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

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On Demand & Self-Paced Options

  • PDF Reference and Resource Materials
  • Post purchase Q&A via emails.
  • Login information will be shared 24 hours after the completion of Live webinar
  • Post purchase Q&A via emails
  • Free shipment within 72 Hours, from the date of webinar completion
  • Listen and read on any compatible device.
  • For International destinations outside US & Canada; please contact our customer support team
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