Initial Importer
and US Agent
Your Mandatory Gateway
to the U.S.
The FDA requires every foreign manufacturer to appoint an Initial Importer – a U.S. based representative with a physical address who is responsible for compliance, product performance, customer complaints, and direct communication with the FDA. Without one, your products cannot legally enter the U.S. market.
The Challenge of Going Alone and Setting up your own importer is possible, but costly and slow:
High fees – $9,000 per year paid directly to the FDA.
Complex compliance – you must create and maintain a Quality Management System (QMS) that documents handling, storage, and complaint procedures.
Delays – building the required infrastructure often takes 3-9 months, with heavy investment in consultants, documentation, and training.
Our Solution:
- Instead of building everything from scratch, you can leverage our existing infrastructure and expertise. Here’s how:
- Immediate Market Entry
We’re already fully registered with the FDA and U.S. Customs (CBP). That means your products can start shipping right away, without waiting months for approvals. Just add our company number to your documents, and you’re cleared for entry.
- Significant Cost Savings
You avoid the $9,000 annual FDA fee, plus the tens of thousands needed to set up and run a compliant QMS. Over five years, that’s a savings of $40,000–$50,000 that stays in your business.
- Guaranteed Regulatory Compliance
Your products operate under our established, FDA-compliant QMS system. Every inspection, every requirement, and every communication with the FDA is covered. You gain peace of mind knowing your products meet all regulatory obligations.
- Focus on Growth, Not Paperwork
While we handle the compliance burden, you can focus on what matters most: developing your products, scaling sales, and growing your business in the U.S. market.
Ready to launch in the U.S. without delays, risks, or unnecessary costs?
Contact us today and let us be your trusted
Initial Importer & U.S. Agent.
