Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
"David R. Dills, Independent Regulatory & Compliance Consultant, with an accomplished record has more than 22 years of hands-on experience "
Import and export process for unapproved and approved medical devices
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. Examine the import and export requirements and ensuring compliance success.
• 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/Authorized Representatives
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel