Exporting and Selling Medical Devices in the United States

Selling medical devices in the USA ensures above-average margins because the price of medical devices and cosmetic machinery in the American market is generally higher than what can be achieved in other markets for the same products. This is why exporting medical devices to the American market guarantees above-average profit margins.

Updated February 24, 2024

The American medical device market is estimated to register sales of 182 billion USD in 2024. Sales are expected to show an annual growth rate (CAGR 2024-2028) of 5.0%, resulting in sales of 262.40 billion USD by 2028.

With 31.27 billion USD in sales in 2023, Abbott Laboratories leads the ranking of the world's largest medical device manufacturers. The Illinois-based company in America surpassed the previous leader, Medtronic, by just 40 million USD. The categories of medical devices with the highest sales volume in the United States are:

• Cardiology Devices.
• Diagnostic Imaging Devices.
• Orthopedic Devices.
• Ophthalmic Devices.
• General and Plastic Surgery Devices.
• Endoscopic Devices.
• Diabetes Care Devices.
• Dental Devices.

Medical device sales in America amounted to 156 billion USD in 2022, with a 7% increase compared to 2021. In 2023, the American electromedical equipment market reached sales of 167 billion USD. The American medical device market is the largest in the world, with a market share slightly over 30% of global sales.

The medical device market in the United States is effectively protected and thus less competitive than others, ensuring those who market medical equipment in America above-average margins. The first step to importing medical devices into the United States is the classification of the medical device. The certification procedure with the FDA then follows from the classification of the equipment.

Importing and Selling Medical Devices in America Ensures Higher Margins Compared to the European Market

Exporting and selling medical devices in the United States certainly requires effort in terms of time, resources, and investments, but ensures higher average margins due to the lower competitiveness of the market. In this sense, the American medical device market follows the economic theories typical of oligopolistic markets to the letter.

It is important to note that in America, the classification standards for electromedical machinery are very different from those in Europe. Equipment for cosmetic use, such as massagers or cellulite treatment machines, are typically considered medical equipment and as such must obtain FDA approval for importation and sale in the United States.

The procedure to obtain FDA certification for the machinery and the import permit can take three to six months and requires close cooperation between the certifying body and the manufacturer or exporter intending to sell the medical device in America. 
For this purpose, it is worth noting that the import authorization into the United States can be requested not only by the manufacturer of the machinery but also by the exporter. And it often happens that the exporter is not the manufacturer.

However, it should be emphasized that the authorization procedure requires providing the FDA with a series of information on the production and assembly process of the machinery that only the manufacturer knows and can provide. It is therefore necessary that there is a complete alignment of intentions between the exporter and the manufacturer of the medical device in cases where the procedure to obtain the export permit to the United States is initiated by the exporter-non-manufacturer.