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:
Who should attend
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,...
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