Export Certificates for Medical Devices

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
90 Minutes
Product Description

Successfully Export your Medical Devices

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 the 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.

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 error, no matter how small can hold-up product approvals, launches, or cause widespread public relation disasters. Therefore, understanding and correct execution of the export certificate processes has become a competitive advantage for global manufacturers of medical devices.

Expert speaker Angela Bazigos, who has 30+ years of experience in life sciences industry, will shed light on execution of export certificate processes, and more!

Areas covered in the session:

  • Background
  • Use of export certificates
  • Types of Certificates (including Export permit)
  • How to choose a certificate type
  • How to request Processing
  • Record keeping
  • Insights on CDRH Export Certification and Tracking System (CECATS)

Who should attend

  • Clinical Trial Physician / Doctor
  • Manager to Senior Director of
  • Regulatory Affairs
  • Quality Assurance
  • Clinical Research
  • Data Management
  • Data Monitoring
  • Institutional Review Board
  • Regulatory Affairs
  • Quality Assurance
  • Clinical Investigators
  • Biostatisticians
  • Institutional Review Boards
  • Data Monitors

Order Below or Call 1-866-458-2965 Today

Order Form

(Select the format below)

Choose Quantity:

(*) Single User Price

You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

About Our Speaker

Angela Bazigos - Pharma Conferences

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...   More Info
More Events By The Speaker

Why AudioEducator?
  • Save money on travel.
  • Meet your specific training needs.
  • Keep learning after the event.
  • Save time training your whole staff.
Join Our Mailing List
Our Accreditation Partners
Facebook Twitter Linkedin Youtube RSS Feeds Google Plus