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

Description

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.

Areas Covered

•    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

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


Speaker Profile

David R. Dills

David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations. He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific. He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and com

Back to Top