Import and Export of Medical Devices Into/From the US: FDA and Custom Rules
Date: February 25, 2025
Time: 12 PM EST
Duration: 60 Minutes
Are you planning to import medical devices into the US or export devices from the US to another country? Do you know that both import and export of medical devices from and to the US requires complex documentation requirements from the importer-exporter before custom clearance. FDA and US customs have created an intricate distribution of responsibilities and tracking system to control incoming and outgoing medical devices. Non-US importers must meet all applicable US medical device regulations in order to import devices into the US. The regulatory requirements include registration of manufacturing site, listing of devices, compliance with QSR, adverse events reporting requirements, and applicable market approvals such as 510(k) or PMA. One needs to designate a US agent and be subject to FDA audits. Similarly, exporter of medical devices, both approved for marketing in the US and unapproved or investigational devices, must provide compliance documents to FDA and customs. This seminar will provide practical instructions in the process of getting import and export documents such as certificates and permits from FDA including description of key terms, concepts, and common issues that importers-exporters of medical devices are likely to encounter.
This seminar is intended for US-based and non-US manufactures importing or exporters medical devices to-from the US who wish to have a better understanding of how medical devices are imported into or exported from the U.S. Attendees will be introduced to the types of documentations, conditions under which FDA issues or denies export certificates or import permits, legal requirements, fees, and regulatory requirements for medical devices. Attending this training will help you to better manage your import and export compliance activities and help support your logistics supply chain.
Areas Covered in the Session:
- FDA’s processes of import and export of medical devices
- Navigating the CECATS
- Notification and Record Keeping Requirements
- Regulatory requirements for medical devices intended for import and export
- Prior Notice process
- Role of US agent for import and export of medical devices
- Dealing with refusal to issue export certificates and import permits
Who will benefit:
The following individuals or disciplines will benefit from attending this Webinar:
- Medical device manufactures, importers and exporters
- 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-Export or Global Trade Directors or Managers
- Import-Export Supervisors
- Customs Brokers
- Companies interested in importing or exporting medical devices to and from the US
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
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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.
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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.
