What Medical Device requirements are verified at the time of importation?

At the time of importation, FDA will verify compliance with the following requirements as applicable:

1. Registration
2. Listing

Additionally:

1. Certain medical devices may need to comply with Premarket Submission requirements (Premarket Notification or Premarket Approval).
2. FDA conducts field examinations and analyzes samples of medical devices to ensure they comply with applicable standards and/or label requirements.
3. FDA checks the import alert database to ensure the manufacturer or product is not subject to detention without physical exam (DWPE) and listed on an import alert. For example, import alert 89-04 lists foreign manufacturers not in compliance with Medical Device Good Manufacturing Processes.