Medical Device Exports | Criticality of FDA Export Certificates
Sustaining competitive advantage within the medical device industry involves a global product strategy requiring Export Certificates in compliance with FDA regulations. Understanding and correct execution of the export certificate processes have become critical.
New Hyde Park, New York, May 15, 2015 (Newswire.com) - 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.
Areas Covered in the Session
- 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
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