UDI, Labeling, and U.S. Agent Compliance for Rollator Exporters

Once FDA registration or 510(k) clearance is achieved, ongoing compliance requires careful attention to labeling, traceability, and communication channels. This guide highlights the essential U.S. obligations for rollator exporters, featuring RELAXSMITH ROLLATOR’s blueprint for traceable and regulation-compliant operations.

1. Unique Device Identifier (UDI) Requirements

• Purpose: Enables electronic tracking of devices in the U.S. supply chain and post-market surveillance.
• GUDID Registration: The Global Unique Device Identification Database (GUDID) houses product-specific data linked to the UDI code.
• RELAXSMITH ROLLATOR Execution: Applies both human-readable and GS1 barcoded UDI on packaging and product frame.

2. Labeling Guidelines (21 CFR 801)

• English Language: Labels and Instructions for Use (IFUs) must be in English, even for multilingual products.
• Essential Elements: Include device name, intended use, manufacturing site, UDI, batch number, and date of manufacture.
• Placement: RELAXSMITH ROLLATOR ensures all labels are visible and durable for storage, shipping, and clinical environments.

3. Appointing a U.S. Agent

• Requirement: All foreign medical device manufacturers must designate a U.S. agent to liaise with the FDA.
• Duties: Receive official communications, respond to inspection requests, and support import inquiries.
• Selection Criteria: RELAXSMITH ROLLATOR partners with experienced regulatory firms that can act as agent and legal interface.

4. Import Logistics and Documentation

• Entry Review: U.S. Customs and FDA may review labeling, invoices, and UDI compliance upon importation.
• Customs Broker: An experienced broker helps manage declaration accuracy and resolve holds efficiently.
• Paper Trail: RELAXSMITH ROLLATOR stores digital copies of labels, import records, and agent correspondence in an FDA-audit-ready format.

5. GUDID Maintenance & Future Trends

• Annual Updates: UDI data must be reviewed and revised as needed, especially with any packaging changes or design updates.
• UDI Integration: Retailers and healthcare providers increasingly require UDI-based inventory systems—compliance is now a market-entry lever.