How to obtain FDA registration for medical devices intended for the United States?

• Register the company and obtain an FDA number
• Pay the annual fee
• Identify the FDA classification of the device
• Enter the U.S. importer information (optional)
• Start exporting with the obtained temporary number

The first step to obtain FDA registration for a medical device is to register the company before the product.
Thus, the company must register with the FDA and obtain an FDA number.

To complete the company registration, it is also necessary to pay the required annual fee to the FDA for medical devices, equipment, and medical/electromechanical accessories.

For the year 2025/2026, the annual fee for FDA registration of medical devices is $11,423

You may be entitled to an exemption from paying the FDA registration fee if:

• You have recorded sales of 1 million dollars or less in the last fiscal year;
• You can demonstrate that paying the registration fee would be a significant financial burden; You have already paid the FDA registration fee in a previous fiscal year.

For the purpose of the registration fee exemption, for actively registered companies, the FDA accepts requests through October 31. For instance, requests related to status for the fiscal year 2026 (from October 1, 2025, to September 30, 2026) will be accepted from August 1, 2025, to October 31, 2025

After completing the company registration, you must then list all the medical devices that this company intends to export to the United States. First, you need to identify the FDA classification of the product, as each medical device is classified with a code by the FDA.

If the company already has an importer, you can also enter the importer information in the FDA company registration, as the importer for America.

At the end of the registration, the FDA issues a temporary registration number, and the final number arrives in 2-3 weeks.
Even with the temporary number, you can export the devices to America.
 

How much does FDA registration cost for medical devices to be exported to the USA?

For registration, you need to pay an annual fee to the FDA: the amount is set year by year. For 2024, it is $7,653 (fda fee for medical device registration).

ExportUSA assists you in the medical sector for the export and sale of electromechanical equipment in the United States.

The entire process of obtaining permits and FDA [Food and Drug Administration] authorization for the import and sale of medical equipment and accessories is managed.