30% of companies will abandon the US market

December 2024 is the deadline to pay the annual US FDA company registration fee for fiscal year 2025.

According to Umedwings US statistics as of December 6, 30% of medical device companies have made it clear that they will no longer pay the annual FDA registration fee.

This increase has undoubtedly increased economic pressure on the Middle East.

In addition, as the regulatory environment in the U.S. market tightens sharply, small and medium-sized enterprises have to face the dilemma of uncertain market growth prospects while facing rising costs.

In particular, the trade war between China and the United States has intensified, making it even more difficult for Chinese medical device companies to expand in the U.S. market.

Therefore, more and more Chinese medical device small and medium-sized enterprises have begun to re-evaluate the investment and returns in the US market, and even have to make the difficult decision to abandon this market.

This decision means that these companies will voluntarily give up their qualifications to enter the US medical device market in 2025.

Compared with fiscal year 2024, all usage costs in the U.S. medical device market in fiscal year 2025 have increased. Specifically, the annual business registration fee in 2025 has increased to US$9,280, an increase of US$1,627 compared with 2024.

To sum up, in the face of multiple pressures such as rising costs, market tightening, and trade wars, Chinese medical device companies are facing unprecedented challenges in their survival and development in the U.S. market. The choices of some companies also reflect the complexity and uncertainty of the current global medical device market structure.

Note: The above statistical data comes from Umedwings US's corporate payment status as the agency for FDA, and does not represent the overall data of the industry.