The Classification of Medical Devices Intended for the American Market

The first step for importation into the USA is the Classification of the medical device into one of the three classes established by the FDA: In the United States, the classification of medical devices occurs in three classes of increasing complexity: Class I, Class II, or Class III
 

FDA Classification of Medical Devices in America

These are the medical specializations covered by medical devices according to FDA regulations [and to which the classification of medical devices for the purpose of 510k registration corresponds, for example]:

• Anesthesiology
• Cardiovascular
• Chemistry
• Dental
• Ear, Nose, and Throat
• Gastroenterology and Urology
• General and Plastic Surgery
• General Hospital
• Hematology
• Immunology
• Microbiology
• Neurology
• Obstetrics and Gynecology
• Ophthalmic
• Orthopedic
• Pathology
• Physical Medicine
• Radiology
• Toxicology

This broad spectrum of medical devices highlights the importance of the sector in providing advanced technologies for the treatment and diagnosis of a wide range of medical conditions.

In the United States, medical devices and cosmetic machinery are categorized into three classes according to their complexity and risk level. The authorization procedure for importation into America begins with the correct classification of the medical device.

The first step is to determine if the product is considered a medical device and if it is therefore regulated by the FDA. The proposed use of the medical device to be imported and its specific operational methods must be examined.

Once it is clarified that it is what the Food and Drug Administration considers a medical device, the first step of the authorization procedure for importation into America of medical and cosmetic equipment [anti-cellulite treatments or even simple massagers] is the correct classification of the equipment intended for import and sale.
 

In the United States, the classification of medical devices occurs in three classes of increasing complexity: Class I, Class II, or Class III

The classification of the equipment is essential to understand the correct procedure for obtaining permission to import and sell the equipment in the American market. The correct classification of the medical-use machine to be imported into America must be done in relation to the 1700 classes of medical devices recognized by the FDA and taking into account the typical use to which the machinery will be assigned.
 

FDA Registration/Authorization to Export and Sell Medical Equipment and Cosmetic Machinery in the United States

Beyond the classification itself, for the importation and sale in the United States of medical devices of any class and type, it is necessary to:

• pay the government fee to the FDA;
• complete the registration of the exporting company with the FDA, and
• appoint an FDA Agent [required by law]
• register the medical device within the company registration.

The government fees to import medical devices into the United States are updated annually and for 2022 are $5662. In reality, this is a fee for the FDA registration of the company. Obviously, without registration it is impossible to import medical devices into America.

The FDA registration procedure concludes with the issuance of the so-called "FDA number" which must be attached to the shipment documentation and the customs import practice in the United States. Once registration is complete, the FDA immediately issues a provisional number with which your company can immediately start exporting to the United States. The final FDA number usually arrives within 90 days.

IMPORTANT:
To import medical machinery into the United States, it is necessary that even the importer is registered with the FDA and has the FDA number.

Review of Labels, User Manuals, and Instruction of Advertising Materials for Medical Devices to be Imported into the USA

Another element to pay attention to when preparing to import medical machinery into the United States is:

• the form and content of the labels,
• the instructions contained in the user manuals,
• the information contained on the company website and
• the information contained in all promotional and advertising material accompanying the sale.

It is necessary to ensure that the machinery is not suggested or, worse, openly proposed for uses that have not been approved by the FDA. In cases where the sale is through an importer, care must be taken to give precise instructions to the sales force so that they communicate only the uses and methods of use allowed by the FDA for that particular medical device.

ExportUSA can assist you in all steps of the process of paying the government fee to the FDA and registering your company with the FDA, also providing the FDA Agent service.

Similarly, we can help you review labels and promotional and advertising materials, as well as compile operational instructions for the sales force that conform to what is approved by the FDA for the imported medical device.