FDA Registration for Medical Devices to be Imported into the United States

The company intending to market medical devices in the American market must complete the registration with the FDA. Upon completion of the registration, the FDA issues a temporary FDA number that must be included in the import documentation for customs clearance of the medical devices.

Contact us for FDA registration of a medical device to be imported into the USA

Usually, within 30 days, the FDA will send the final registration number. Other necessary elements for FDA registration, in addition to the exporting company's information, include:

• Description of all the medical devices intended for import;
• Business name and address of the manufacturing company if the exporter and distributor are two different companies;
• Classification of each device according to the FDA taxonomy by class, subclass, and corresponding code;
• Details of the FDA Agent for the American market. The FDA Agent is a mandatory figure and serves as a contact with the FDA for all communications regarding the products included in the registration and the company itself;
• Authorization number 510k for medical devices that require this particular type of import authorization. Remember that the 510k procedure always and only concerns a subclass of Class II medical devices;
• Authorization number of the type PMA - Pre Market Authorization for all those Class II medical devices that require this import authorization procedure;
• DUNS Number of the company. This is a unique number assigned to the company by Dun & Bradstreet. The number can be requested online and for FDA registration purposes, it is issued free of charge. Note: It is crucial that the business name and address used for registration are PERFECTLY identical to those used when requesting the DUNS number, respecting spaces and punctuation. Example: if you wrote "s.r.l." when requesting the DUNS, you cannot write "SRL" when registering with the FDA, under penalty of rejection of the registration;
• Payment of the FDA registration fee. For the period from October 1, 2023, to September 30, 2024, the amount to be paid is $7,653. The registration fee must be paid annually, and the amount is updated annually to adjust for inflation. The registration form must include the PCN - Payment Confirmation Number issued after the fee has been successfully paid.

  Example of medical device registration by an Italian company

  The FDA registration of medical devices is included in a publicly accessible database that anyone can consult. We provide, as an example, the FDA registration of the company ELCAM MEDICAL ITALY SPA. In the registration form, the acronym "FEI" stands for "firm or facility establishment number" and corresponds to the DUNS number. Note how the Italian company established an American entity, ELCAM MEDICAL INC., which acts as the FDA Agent and, most likely, also as an importer for the American medical device market. Remember, it is not necessary to establish your own company to import and sell in America. The fact that ELCAM MEDICAL ITALY SPA did so indicates that sales in the United States are significant enough to justify such an import and distribution structure.

  Establishment:
  ELCAM MEDICAL ITALY SPA
  15, VIA EMILIA-ROMAGNA
  CARPI Modena, IT 41012
  Registration Number: 300xxxxxxx
  FEI Number*: 300xxxxxxx
  Status: Active
  Date Of Registration Status: 2024
  
  Owner/Operator:
  ELCAM MEDICAL ITALY SPA
  15, VIA EMILIA-ROMAGNA
  CARPI, Modena IT 41012
  Owner/Operator Number: 9094403
  
  Official Correspondent:
  Name Surname
  15, VIA EMILIA-ROMAGNA
  CARPI, Modena IT 41012
  Phone: 123456789
  
  US Agent:
  Name Surname
  ELCAM MEDICAL INC.
  1 University Plz
  SUITE 511
  Hackensack, NJ US 07601
  Phone: 123456789 Ext 112
  Fax: 123456789
  Email: name@email.email