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

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Things you Need to Know before Importing Products Regulated by US FDA and Customs Department

The FDA and US Customs have special requirements for importing regulated products in the country which could either be finished products for sales in the US or raw material or components imported for use in manufacture in the US. These products could be prescription drugs and biologics, medical devices, over the counter drugs, dietary supplements, cosmetics, or medical foods. Importers are required to provide detailed documentation regarding the compliance status of imported material, the country of origin, export documents from the country of origin, the destination in the US, purpose of the import, registration documents, chain of control, and several other elements. Incomplete, inadequate, or erroneous documents are the most common reason for delays in the release or refusal to enter at the US customs.  

This seminar will provide practical instructions in the process of import of FDA-regulated products including description of key terms, concepts, and common issues that importers of FDA-regulated products are likely to encounter.

This seminar is intended for importers of FDA regulated products or those that 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. Attendees will be introduced to 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.

Training Objective:

  • FDA entry review process
  • US Customs import documentation requirements
  • US Customs bond requirements
  • HTS classification of regulated products
  • FDA import product codes
  • FDA import affirmation of compliance codes
  • FDA Prior Notice
  • FDA ITACS system
  • Role of US import agent
  • Dealing with refusal to entry or delay in entry hold
  • And more!!

 Points to be covered:

  • Rules for Import for Products in to US
  • FDA Import Law
  • FDA Interpretation of the Law
  • Products Imported into the US
  • The Import Process
  • Examination and Sampling
  • Detention process
  • Import alerts
  • Importer of Record (US Agents/ Licensee/ Manufacturer)
  • Customs Broker
  • The Exporter in COO
  • Harmonized Tariff System (HTS)
  • FDA Product Code
  • Prior Notice(PN) Process
  • PN Documentation Requirements
  • PN Documentation for Medicinal Products
  • Practical Tips
  • What to expect in the Near Future

Who Should Attend:

  • U.S. importers of FDA regulated products
  • Foreign exporters of FDA regulated products (companies which sell regulated products to U.S. importers)
  • Compliance officers
  • Logistics/Supply chain managers and analysts
  • Trade regulatory/legislative affairs professionals
  • Sales/marketing personnel
  • International business operations
  • Customs or Trade Compliance Personnel or Officers
  • Import or Global Trade Directors or Managers
  • Import Supervisors
  • Customs Brokers

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
More Events By The Speaker

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