FDA Export Certificates for Medical Devices

Larry Spears
Instructor Larry Spears
Product Id 601506
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

FDA Export Certificates for Medical Devices

Overview:
Companies need to stay internationally competitive and this webinar on export certificates provides a key link for entry to markets around the globe. This webinar will explore the export approval and certification process in the U.S. It will include guidance on preparing applications and obtaining FDA's certification that specific products identified for export meet U.S. regulatory requirements. All of this will be valuable in obtaining broader access to global markets.

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.

Areas Covered in the Session:
  • Purpose of Presentation
  • Background
  • Use of export certificates
  • Types of Certificates (including Export permit)
  • How to choose a certificate type
  • How to request Processing
  • Record keeping
  • CDRH Export Certification and Tracking System (CECATS)

Who Will Benefit:
  • Marketing Specialists
  • Compliance and Regulatory Associates
  • Managers to Senior Directors of:
    • Export Programs
    • Regulatory Affairs
    • Quality Assurance
Speaker Profile
Larry Spears,/b> is a former CDRH Office of Compliance Director and Manager with over 20 years experience in administering regulations for the medical device industry and is currently an independent consultant to the medical device and pharmaceutical industries. His expertise in the exports area is derived from his years at CDRH where he made regulatory decisions that impacted the export program and the industry governed by it.

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