Import of FDA Regulated Products into the US: FDA and Custom's Requirements at the Port of Entry

Duration: 60 Minutes
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 manufacture in the US. FDA-regulated products covered in this webinar 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 reasons for delays in the release or refusal to enter at the US customs.
Import requirements for FDA regulated products
Instructor: Mukesh Kumar
Product ID: 500819

This webinar 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 Attend:
This webinar is intended for importers of FDA regulated products or those that sell regulated products to the 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.

Objectives of the Presentation:
This webinar aims at providing in-depth knowledge on:
  • 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 can Benefit:
  • 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

This webinar is a part of "Import Export Regulations" Webinar Series. Click here to know more.


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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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