The FDA does not recognize regulatory approvals obtained in other countries, therefore foreign firms that manufacture medical devices imported into the United States need to comply with applicable US regulations before doing so.
- Importers should ensure that they comply with the following:
- Establishment is registered with the FDA
- Devices have been listed with the agency
- Devices are manufactured in compliance with FDA's Quality System Regulations or QSR
- Adverse events related to medical devices are reported in a compliant manner
- Premarket Notification (510(k)) or Premarket Approval have been obtained from the FDA for any device to be imported into the US
- Foreign manufacturers should have a designated agent in the US.
In addition to FDA regulations, the importers must also comply with Customs and Border Patrol (CBP) requirements.
To get a detailed account of all regulations and best practices for medical device import download this free whitepaper on medical device import.
Also you can attend the seminar -FDA's Import Requirements and Managing the Import of FDA Regulated Products: 2-day In-person Seminar