Webinars >>FDA Regulations
Import of FDA Regulated Products into the US: FDA and Custom’s Requirements at the Port of Entry

FDA and US Customs have special requirements for allowing entry of regulated products.
Regulated imports could be finished products for sales in the US or raw material or components imported for use in manufacture in the US. FDA-regulated products covered in this seminar include 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.
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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.  
Why should you atte​nd:
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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.
Areas Covered in the Session:
  • 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
Who will benefit:

The following individuals or disciplines will benefit from attending this Webinar:
  • 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
Date: May 29, 2018
Time: 12 PM EST
​Duration: 60 Minutes

Speaker
Mukesh Kumar, PhD, RAC
Brij Strategic Consltations,        USA ​

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com