export-certificate-for-medical-devices-–-edge-out-your-competition

Export Certificate for Medical Devices – Edge Out Your Competition!

Live Webinar

  • 90 minutes

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.

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.

Join this session by expert speaker Angela Bazigos, where she will explain 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.

Session Highlights:

  • 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)

Why You Should 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.

Who Should Attend:

  • Clinical Trial Physician /Doctor

  • Managerto Senior Director

  • Regulatory Affairs

  • Quality Assurance

  • Clinical Research

  • Data Management

  • Data Monitoring

  • Institutional Review Board 

  • Biostatisticians

  • Data Monitors


*You may ask your Question directly to our expert during the Q&A session

** You can buy On-Demand and view it as per your convenience


Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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