U.S. Import of FDA Regulated Products: Understanding the Entry Process

Instructor: Reynaldo Roman
Product ID: 703230
Training Level: Intermediate
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This trade webinar will explain the complex US entry process so companies that import FDA regulated products will benefit from a better understanding of how the process works. It will discuss factors and actions that can lead to an import shipment being delayed or not allowed entry into the USA.

Why Should You Attend:

U.S. Importers of FDA regulated products must know and comply with FDA and Customs’ import requirements. They are expected to use reasonable care when making entry on their merchandise and be prepared to demonstrate compliance with U.S. health and safety standards.

Attend this webinar if you are importer of FDA regulated products or sell regulated products to U.S. importers and wish to have a better understanding of how FDA regulated products are entered into the U.S. Those new to importing FDA regulated products will also benefit from this webinar because we will explain some of the key terms, concepts and issues U.S. importers of FDA regulated products are likely to encounter. We will discuss the Customs entry process, Customs bond requirements for regulated products; HTS classification of regulated products; FDA import product codes; FDA affirmation of compliance numbers and the FDA entry.

Attending this training will help you to better manage your import compliance activities and help support your logistics supply chain.

Learning Objectives:

  • How to manage the entry process to ensure import compliance and timely release of merchandise.
  • Tips on classifying FDA regulated products
  • How to find an FDA import product code

Areas Covered in the Webinar:

  • Customs entry process
  • Customs bond requirements
  • Common U.S. Import documentation
  • Common U.S. trade terms and definitions
  • HTS classification of regulated products
  • FDA import product codes
  • FDA import affirmation of compliance codes
  • FDA Prior Notice
  • FDA ITACS system
  • FDA entry review process

Who Will Benefit:

  • 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
  • Customs Brokers

Instructor Profile:

Reynaldo Roman, is a licensed U.S. Customs Broker and Certified Customs Specialist with more than eighteen years experience in Customs brokerage and U.S. trade compliance. During his career, Reynaldo has managed Customs’ brokerage teams, worked as a compliance analyst at a large international importer and completed high-level trade compliance assignments such as product line classification and Customs protest and duty refund projects. He has gained specialized knowledge in the areas of pharmaceutical and medical devices, cosmetics and food products and consumer electronics and textiles.

In his current role, as senior manager of trade compliance at Marken, a world leader in providing logistical services to the pharmaceutical, biotechnology and clinical research industries, Reynaldo supports operations and clients in ensuring that the trade regulatory requirements of Customs and other government agencies are met.

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