The document summarizes FDA regulations regarding importing and exporting medical devices. It states that any medical device legally in the US can be exported without FDA approval, but devices not approved in the US must follow export provisions. It also notes that foreign manufacturers importing devices into the US must comply with regulations before, during and after import, and all imported devices must meet Customs and Border Protection requirements as well as FDA requirements. Devices not meeting FDA standards may be detained upon entry.

1. FDA Regulations for Importing and Exporting
Medical Devices
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2. Instructor Profile
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at
Amarex Clinical Research, a full service CRO based in Germantown, MD. His key
expertise is in developing Global Regulatory Business Strategies for biomedical
product development and his passion is to bring traditional therapies for India, China
and the Latin-America to the Western markets. In addition to regulatory expertise,
Mukesh is an experienced auditor and a trainer in regulatory and business processes.
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3. Description
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
applies to unapproved devices. 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. 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.
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4. Why Should Attend
This Webinar will provide a broad overview of the
requirements and expectations and an
introduction to the regulations, including
21 CFR1, 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
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5. Objectives
 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
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6. Who can Benefit
 Regulatory Affairs
 Clinical Affairs
 Quality and Compliance
 Marketing & Sales
 Distributors/Authorized
 Representatives
 Engineering/Technical
 Services/Operations
Consultants
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7. How this Webinar Works
 Username and Password will be sent to
you 24 hours prior to the webinar
 Presentation handouts in pdf format will
be mailed to you
 Login to the session using the username
and password provided to you
 Get answer to your queries through
interactive Q&A sessions via chat
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Track the link:
FDA Rules-Medical Devices

8. Connect with Us
Online Compliance Panel
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com