International Issues for Medical Device Manufacturers: An Introduction
A session from FDLI’s Introduction to Medical Device Law and Regulation
Recorded April 9, 2025
International Issues for Medical Device Manufacturers: An Introduction
Understand the legal framework concerning imports and exports of medical devices. Recall the basis of approved and unapproved devices. Examine the importation process.
Sarah H. Stec, Assistant General Counsel, Regulatory Law, Johnson & Johnson
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in April 2025.
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SARAH H. STEC is senior counsel, medical device regulatory law at Johnson & Johnson. Stec has experience in assisting healthcare and life sciences companies understand new and evolving regulatory duties, including how those international regulations can work together, as well as providing guidance on international corporate accreditation and regulatory issues. Her background in quality systems and experience with international regulators gives her a unique view on the legal and regulatory requirements for medical device, pharmaceutical, and food manufacturers.
































































































