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
- International Distributors/
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/
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