Import of FDA Regulated Products into the US: FDA and Custom’s Requirements at the Port of Entry
Date: May 29, 2018
Duration: 60 Minutes
Time: 12 PM EST
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.
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.
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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
We accept credit card, debit card, and PayPal.
Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
