Medical Device Export Approvals and Certificates in compliance with FDA regulations

    /Larry  /Spears speaker of compliance global
    Speaker: Larry Spears
    Duration: 90 Minutes
    Product Code: 700102
    Level: Beginner
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overview

Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products’ status as regulated by the FDA. An export certificate is a document prepared by FDA that has information about a product’s regulatory or marketing status in the U.S.

The rules that companies must follow when exporting medical devices depend on whether or not their devices have been approved or cleared by the Food and Drug Administration.

Certificates to Foreign Governments are the most frequently requested type of export certificate, but export certificates may also be requested when exporting devices under sections 801(e)(1) and 802 of the FD&C Act or when exporting non-clinical research-use-only devices.

why should you attend

In today’s global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries. To this end, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations. In submitting export certificates, any mistake, no matter how minor, can delay product approvals, launches, or cause widespread public relations disasters. Therefore, understanding and correct execution of the export certificate processes has become a competitive advantage for global manufacturers of medical devices.

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Areas Covered

  • Use of export certificates
  • Types of certificates (including Export permits)
  • How to choose a certificate type
  • How to request processing
  • Record keeping
  • CDRH Export Certification and Tracking System (CECATS)

Learning Objectives

•  Foreign government expectations regarding US entry products
•  Requirements to obtain certificates
•  Export certificate uses for global marketing advantages
•  FDA registration certificate processing operations

WHO WILL BENEFIT

•  Regulatory Affairs Managers / Senior Directors
•  Quality Assurance Certification Managers / Senior Directors
•  Clinical Research Training Managers / Senior Directors
•  Data Management System Managers / Senior Directors
•  Data Monitoring Managers / Senior Directors
•  Regulatory Professionals
•  Regulatory Consultants
•  Quality Professionals
•  Small Business Owners

SPEAKER

Larry Spears has deep regulatory expertise from over 35 years' experience in government and consulting. This includes investigations, compliance and regulatory roles with FDA including senior compliance leadership positions in the CDRH Office of Compliance, as a consultant with a large life sciences consulting firm and as an independent consultant. Mr. Spears provides global regulatory strategy consultation to Life Science companies primarily in medical devices/diagnostics and pharmaceuticals with a focus on quality systems gap assessments, FDA mock inspections, quality system development and planning, and remediation for FDA inspection findings including, CAPA and complaints, design controls, supplier controls, production management, and training

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