Entering the US MedTech market is a major achievement, but maintaining that access requires navigating critical annual compliance tasks. This episode explores the often-underestimated risks of the FDA establishment registration and device listing renewal process, a simple task that can lead to severe consequences if missed. We discuss how a simple administrative oversight can halt multimillion-dollar shipments at the border and freeze your US sales.

We unpack a real-world case where a successful European company's US launch was derailed overnight because they missed the renewal deadline. This episode highlights the strategic advantage of partnering with a single, dedicated team to manage this process year-round, ensuring your market presence is secure and uninterrupted.

This episode's key takeaways:

1. Why is the October 1st to December 31st window a make-or-break period for your US business?.

2. What are the immediate, costly consequences of missing the FDA renewal deadline?.

3. How does a designated US Agent act as your first line of defense against shipment detention?.

4. Is your current process for handling FDA notifications robust enough to prevent a crisis?.

5. What is the difference between treating FDA registration as a one-time project versus a continuous process?.

6. For non-US companies, what is the single biggest point of failure in the annual renewal process?.

7. How can a unified regulatory partner turn a simple compliance task into a strategic advantage?.

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