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 andor products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before Zach Werenski Blue Jackets Jersey , 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 regulatory requirements may be detained upon entry.


This Webinar will provide a broad overview of the requirements and expectations and an introduction to the regulations, including 21 CFR 1 Sergei Bobrovsky Blue Jackets Jersey , 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 Artemi Panarin Blue Jackets Jersey , 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 Seth Jones Blue Jackets Jersey , 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 the session:

Examine the import and export requirements for medical devices Introduction to FDA references and guidance documents related to import and export requirements 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: This webinar will provide valuable assistance and guidance to device companies involved in importing and exporting of medical devices. Employees who will benefit include:

All levels of management and departmental representatives and those who desire a better understanding or a “refresh“ overview of the exportimport process Regulatory Affairs Clinical Affairs Quality and Compliance Marketing & Sales DistributorsAuthorized Representatives EngineeringTechnical ServicesOperations Consultants

GlobalCompliancePanel plays a role of bringing together the regulators or experts on regulation with the community who needs to learn or be aware of those regulations. GlobalCompliancePanel is started with the goal to create an excellent interactive platform for the experts and the user community thereby making costs of training more affordable with increased convenience.


GlobalCompliancePanel strives to understand the changing customer needs and enrich their quality of life by simply providing world-class training to increase their productivity and professional growth. Global Compliance Panel enables the companies in triggering business processes through regulatory notifications and industry alerts.