Import of FDA Regulated Products into the US: FDA and Customs Requirements at the Port of Entry

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, a listing of devices, manufacturing in accordance with the quality system regulation and medical device reporting of adverse events.

• What are the importing filing processes?
• What are the FDA agencies responsible for overseeing import?
• How are the FDA-Regulated Product procedures used within the importation process?
• What are the customs requirements?
• Why are the administrative forms used in the importation process?
• How to complete the general certificate of compliance and certification of conformity documentation in the importing process?
• Complying with customs regulations: Why is it considered a valuable assessment tool for the FDA Regulatory process?

• Review the role of the import managers when shipping goods under the FDA and customs regulations
• How the regulations can be used to help the importer in understanding FDA guidelines in accordance with U.S. Port of Entry requirements in developed and developing markets?
• FDA procedures and evaluation criterion that will have an effect on the logistics transactions of your company
• The classification and valuation of the FDA goods for importing purposes within their dutiable status
• What are the proper documentation procedures to meet the country of origin requirements?
• Does your FDA import documentation meet foreign law requirements?

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.

• U.S. importers of FDA regulated products
• New U.S. importers of FDA regulated products
• Foreign exporters of FDA regulated products (companies which sell regulated products to U.S. importers)
• Purchasing department personnel for U.S. importers of FDA regulated products
• Compliance officers
• Logistics/Supply chain managers and analysts
• Trade regulatory/legislative affairs professionals
• Sales/marketing personnel
• Training personnel
• Consultants
• International business operations
• Chief Executive officers
• Customs or Trade Compliance Personnel or officers
• Import or Global Trade Directors or managers
• Import supervisors

Dr. 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, and supply chain management. Dr. Gerald worked with small and medium-sized businesses to help improve their business logistic processes through verification of operational and supply chain programs. Also, he had developed management and marketing strategies that were used to improve the efficiency and effectiveness of his client business operations in this global economy. 

He earned a Doctor of Business Administration in International Business and Advanced Professional Business Certification in Marketing from Argosy University/Sarasota; He also holds a Master of Science of Law (J.S.M.) degree and certificate in Compliance & Risk Management from Thomas Jefferson School of Law in International Tax and Finance Services. He has also recently completed his MBA in Project Management from the University of Phoenix.

Dr. Gerald is also a member of the Free Trade Alliance, San Antonio Transportation Association, Inc., San Antonio SCORE, TX, Supply Chain Council and Institute of Business Forecasting & Planning, and CATO Institute of Research & Analysis and Academy of Business Research. He is a Certified Supply Chain Manager, and Inventory Planner and Property Forecaster, Certified Consultant for Business Value Analysis and Methodology, Certified Export Leaders of the Free Trade Alliance and Casa of San Antonio, TX; Certified Master Management Consultant and Master Project Manager; and Certified Marketing Analyst and Registered Business Analyst by the International Management Consultant Certification Board (IMCB). 

Certified CCA ™ Chartered Compliance Analyst AAFM ® American Academy of Financial Management/ Certified International Project Manager (CIPM) of the AAPM ® American Academy of Project Management. A member of the Council of Supply Chain Management Professionals; and an Advisor for the Mu Kappa Tau Marketing of the Honor Society. He has published scholarly papers for the Journal of International Business and Economics and the Strategic Management Quarterly.