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

Event Information
Product Format
Prerecorded Event
60 minutes
Product Description

FDA Regulations & Customs Requirements for Import of Medical Device or Products

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

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.

Learning Objectives:

  • 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?

Session Highlights:

  • 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?

Who Should Attend

  • Company Executive Officer (CEO)
  • Entrepreneurs
  • Distributor Channel Managers
  • Health Service Providers
  • Wholesalers Perishable Goods
  • Grocery Retailers
  • Logisticians

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About Our Speaker

Dr. Rossano V. Gerald

Dr. Rossano V. 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, supply chain management; and is a veteran of the United States Army. He has worked with small and medium-sized businesses to help improve their logistic business processes through verification of operational and supply chain programs.  Also, He has developed management...   More Info
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