FDA U.S. AGENT

As part of the FDA’s Medical Device Registration and Listing requirements, establishments outside the United States must designate a U.S. Agent. Click here for more information.

Preferred Depot provides U.S. Agent services to international clients in various FDA regulated areas to register the facility or products as needed.

By acting as a liaison and responding to questions and concerns in a timely manner, Preferred Depot helps clients get their compliant products to the U.S. marketplace as quickly as possible.

IMPORTATION

In order to import medical devices into the United States, foreign medical device, in-vitro diagnostics and/or radiation emitting product manufacturers must comply with the regulations set by the FDA.

Adherence to these regulations is required before, during, and after importation, as the FDA does not recognize compliance with other regulatory bodies.

Preferred Depot acts as a conduit between our clients’ companies and the FDA, responding to inquiries regarding their products and providing comprehensive assistance to ensure import compliance.

LOGISTICS & SUPPORT

As your chosen U.S. Logistics Center, Preferred Depot sets up, deploys and handles your demonstration equipment, finished goods installations and return material authorizations. We provide our partner companies with an ideal operating environment and flexibility, ensuring cost reduction, risk mitigation and increasing visibility across your entire value chain.

Our logistics services include:

• Service and repair
• Finished goods installation
• Return material authorization (RMA)
• Inventory management
• Established SOPs and KPI reporting
• Reverse logistics for recalls