Areas covered in the session:
* 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
* 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
