Foreign firms that manufacture medical devices and/or products that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. In order to import medical devices and/or products into the U.S., the product must meet FDA regulatory requirements. FDA does not recognize regulatory approvals from other countries. These requirements include registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation and medical device reporting of adverse events.
Join expert speaker Dr. Rossano V Gerald in this session that provides guidance on how to access FDA agency documentation addressing the strict requirements of imports of goods for health and safety reasons. These regulatory requirements may have an effect on the importer when it comes to the variety of product ingredients. For example, it will address the agricultural commodities and Food, Drugs and Cosmetics that may be marked as adulterated, mislabeled or misbranded by using procedural examples and cases. This webinar will also provide importers of FDA-regulated goods with guidance on U.S. Customer Border Protection regulations for international logistic transactions.
Who Should Attend
- Dr. David Lim
Dr. Rossano V. Gerald is an Academic Professor and Founder of RVG International Consulting Firm, LLC. He has over twenty-five years of business experience in, strategic management, marketing analysis, supply chain management; and is a veteran of the United States Army. He has worked with small and medium-sized businesses to help improve their logistic business processes through verification of operational and supply chain programs. Also, He has developed management...
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