Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

In this medical device training on Importing and Exporting learn and understand the import and export process for unapproved and approved medical devices and the documentation process involved.
March 15, 2011 - PRLog -- 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 apply to unapproved devices. But 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.

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. regulations before, during, and after importing into the U.S. or its territories. 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).

This Webinar will provide an overview of the requirements and expectations and an introduction to the regulations, including 21 CFR 1, Subpart E--Imports and Exports. We will discuss the documentation process and the record keeping requirements. This webinar will provide direction and guidance to device companies involved in importing and exporting of medical devices.

Areas Covered in the Seminar:

- 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 direction and guidance to device companies involved in importing and exporting of medical devices.
All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the export/import process, including:

- QA and Compliance
- Regulatory Affairs
- Marketing/Sales
- Consultants
- International Distributors/Authorized Representatives

Instructor Profile:

David R. Dills, Independent Regulatory & Compliance Consultant, with an accomplished record has more than 22 years of hands-on experience with emphasis on Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of QA, Regulatory Affairs and Compliance. Since 2000, has provided consultative services on behalf of global manufacturers and subcontracted by third-party consultancies and provides services involving all key stages of the product development, submission, and commercialization process, inspection readiness preparation, GxP compliance, execute audits and regulatory assessments, execute remediation and regulatory strategies, postmarketing surveillance/vigilance reporting, clinical affairs, deploy and remediate QMS and documentation systems, preparation for ISO 13485 registration and CE Mark, and multi-country device registrations. He has been previously employed, with increasing responsibilities by medical device firms and consultancies, including a globally recognized CRO.

For more details:

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Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates.
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Tags:Compliance Training, Web Event, Web Conferencing, Web Seminar, E-learning, Medical Devices, Medical Device Webinar Training
Industry:Medical, Event, Education
Location:Palo Alto - California - United States
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