Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements - By Compliance Global Inc.

This Webinar will provide a broad overview of the requirements & expectations and an introduction to the regulations, including 21 CFR 1, Subpart E-Imports & Exports. Understand the regulatory process if you are a foreign manufacturer & want to sell your device in the U.S


Any Medical Device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture Medical Devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. customs regulations before, during, and after importing into the U.S. or its territories.

All Medical Devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not meet FDA rules & regulations may be detained upon entry.

Why Should You Attend:

This Webinar will provide a broad overview of the requirements and expectations and an introduction to the regulations, including 21 CFR 1, Subpart E-Imports and Exports.

Entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. Product information should include device name and product code. The affirmation of compliance should include: importer registration number, foreign establishment registration number and name of U.S. agent, Medical Device listing number, and Premarket Notification 510(k) or Premarket Approval number, if applicable.

For exporting, while FDA does not place any restrictions on the export of devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificate for Foreign Government (CFG). Learn the process for unapproved and approved medical devices to be exported and the documentation process involved.

Areas Covered in this Webinar:

• Examine the import and export requirements for Medical Devices
• Introduction to FDA references and guidance documents related to import and export requirements

Learning Objectives:

• Understand the regulatory process if you are a foreign manufacturer or initial importer and want to sell your device in the U.S.
• Import alerts
• Recordkeeping requirements and your responsibilities
• How to export unapproved and approved Medical Devices

Who Will Benefit:

• All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the export/import process
• Regulatory Affairs Personnel
• Clinical Affairs Personnel
• Quality and Compliance Professionals
• Marketing and Sales Professionals
• Distributors/Authorized Representatives
• Engineering/Technical Services/Operations Personnel
• Consultants



For registration:

Contact Details

Company Name: Compliance Global Inc.
Issued By: Compliance Global Inc.
Phone: 15169005515
Address: 2754 80th Avenue
City: New Hyde Park
State: New York
Zip: 11040
Country: United States
Website: Visit the website

Keywords : FDA approval, fda approved drugs, fda drug approval, FDA notification, fda device approval, fda approval process, new fda approved drugs, U.S. regulations, us customs regulations, us export regulations, laws of usa, FDA regulations, fda rules and regulations, fda import regulations, fda guidance, fda guidelines for food, compliance regulations,

by Compliance Global Inc. (few years ago!)

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