A Beginners Guide to Importing Medical Devices

Many companies that import medical devices are either unaware that the product is in fact a medical device, or unaware of FDA’s requirements related to medical devices. This seminar is intended to assist with a basic overview of what medical devices are, how to identify if you are in fact importing one, and if so, what the FDA’s requirements really are to do so.

Areas Covered in the seminar:
Seminar is to inform the international trade and transportation community regarding the FDA policies and procedures related to medical devices.

• What is a Medical Device?
• Checklist Best Practices for Importing Medical Devices .
• Medical Devices Classes.
• Premarket Notification - 510 (k).
• Premarket Approval (PMA).
• Establishment Registration FDA Form 2891.
• Quality System Regulation (QSR).
• Due Diligence - Medical Device Reporting.
• Medical Device Listing FDA Form 2892.

Who Will Benefit:

• Importers
• Customs Brokers
• Warehouses
• Air and Ocean Carriers
• Trucking companies
• Consultants
• International attorneys
• International Bankers
• Others interested in medical devices

Instructor Profile:

Jennifer Diaz, is a Board Certified International Attorney who is considered an “expert” in international law by the Florida Bar. She joins an elite group of Board Certified International attorneys in Florida and is among the youngest attorneys to accomplish this feat. She leads the Firm's Customs and International Trade practice assisting clients with issues relating to the import and export of merchandise to and from the United States.

She has experience working with Federal agencies including the U.S. Food & Drug Administration (FDA), U.S. Customs and Border Protection (CBP), U.S. Department of Homeland Security (DHS), U.S. Environmental Protection Agency (EPA), and Alcohol and Tobacco Tax and Trade Bureau (TTB) on issues relating to proper FDA labeling to registration requirements and entry procedures for cosmetic, over the counter drug, dietary supplements and medical device products; FDA voluntary recalls; classification of goods; antidumping matters; scope ruling requests; seizures, forfeitures, and mitigation of fines and penalties; Customs-Trade Partnership Against Terrorism (C-TPAT); trademark recordation and infringement. Jennifer has also successfully drafted Protests, Prior Disclosures, CBP Binding Ruling Requests, Freedom of Information Act Requests, and responses to CBP's Request for Information (CF 28) and Notices of Action (CF 29).

Jennifer’s expertise is in successfully

• Successfully represented various importers in obtaining the release of cargo that was either detained or seized by CBP.
• Successfully assisted importers in cancelling, or substantially mitigating either liquidated damages or penalties from CBP.
• Negotiated successful settlement agreements with various other federal government agencies such as EPA and Federal Communications Commission (FCC) for the release of seized cargo.
• Substantially mitigated penalties assessed from the Office of Foreign Assets Control (OFAC) for alleged violations of Cuban Embargo.
• Successfully represented alcohol and tobacco importers in obtaining importer permits with the Alcohol and Tobacco Tax and Trade Bureau (TTB).