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

Examine the import and export requirements for medical devices

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 the Session:Examine the import and export requirements for medical devicesIntroduction to FDA references and guidance documents related to import and export requirementsUnderstand the regulatory process if you are a foreign manufacturer or initial importer and want to sell your device in the U.S. Import AlertsRecordkeeping requirements and your responsibilitiesHow to export unapproved and approved medical devicesWho Will Benefit:All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the export/import processRegulatory AffairsClinical AffairsQuality and ComplianceMarketing & Sales Distributors/Authorized RepresentativesEngineering/Technical Services/OperationsConsultants


12 May 2015 @ 10:00 am

12 May 2015 @ 11:00 am

Duration: 1 hours

Timezone: GMT -8:00


Online Webinar



Organised by

NetZealous (deactivated)

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