This seminar is intended to assist with a basic overview of what medical devices are... Seminar is to inform the international trade and transportation community regarding the FDA policies and procedures related to 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.
What is a Medical Device?
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.
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
Course Provider
Jennifer Diaz,
