Topics
- Introduction to FDA references and guidance documents related to import and export requirements
- Import and export requirements for medical devices
- Import Alerts
- The regulatory process if you are a foreign manufacturer or initial importer and want to sell your device in the U.S
- How to export unapproved and approved medical devices
- Recordkeeping requirements and your responsibilities
Who should Attend
Attendees involved in design, project management, purchasing, production, servicing, installation, record keeping activities for medical device manufacturing and document control.
