The facility registration procedure means that the owner or operator of a business (facility or facility) involved in the production or distribution of medical devices intended for distribution in the United States shall register the business with the US Food Registry for an annual period.
The US Food and Drug Administration has been authorized by the US Congress to receive annual registration fees from businesses.
Documents about the subject of registration and payment are detailed in the registration of the facility and the object of payment. Annual registration fees are collected at the same amount for SMEs and all other businesses.
The annual registration fee from 2016 to 2017 is shown below.
Year FY 2016 / FY 2017
Fee USD 3,845 *USD 3,872
* The above amount is not a fixed amount and the fixed amount will be announced in August before the receipt of the cost for the year.
Almost all business entities must be registered with the device and must also provide information on which production activities they are responsible for in the production of the products being manufactured in the field. If the product is a PMA or 510 (k), the owner or operator of the business must complete the relevant procedures (510 (k), PMA, PDP, HDE).
Changed Medical Device User Charges According to the Modernization Law (since Sep. 30, 2007), information on registered businesses and products must be submitted in electronic form unless otherwise approved.
The vendor and product registration process will provide information on the type and manufacture of the product to the US Food and Drug Administration.
This information raises the country's ability to cope with public health emergencies.
• Medical device manufacturers are required to pay the annual registration fee from October 1 to December 31 every year.
• Medical device manufacturers must provide registration information to the US Food and Drug Administration from October 1 to December 31. Companies that have already been registered will
Regardless of whether or not you need to review and update your registration information every year.
• For overseas manufacturers, the D-U-N-S number must be issued to complete the registration process.
• Regardless of the completion date of the registration process, including payment of the registration fee, the registration information must be renewed annually and in the next year
Registration fees for the registration must be paid.