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Every company that is involved with production or distribution of medical devices intended for the USA (manufacturer, packager, exporter, importer, specification developer, etc) must: register with US FDA, list the devices by category, and if foreign, must have a US Agent.
Each year by December 31st, each registered company must renew its registration.
Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. The regulations for establishment registration are provided in 21 CFR 807. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. Congress has also authorized FDA to implement a user fee for certain types of establishment registrations processed after September 30, 2007. Your registration is not considered complete until FDA has been notified that all requirements have been met.
Any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution.
Owner / Operator
The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment. The owner/operator is responsible for registering the establishment.
Registration of an establishment is not an approval of the establishment or its products by FDA. That is, it does not provide FDA clearance to market. Unless exempt, premarketing clearance or approval is required before a device can be placed into commercial distribution in the U.S.
Misbranding by Reference to Establishment Registration Number: Title 21 of the Code of Federal Regulations, Section 807.39, states, "Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding." Product labeling and Internet sites cannot reference your establishment registration number or make reference to your establishment being registered or approved by FDA. If your product labeling or Internet sites list your establishment registration number or makes reference to your establishment being registered and approved by the FDA, then these references must be removed.
Who Must Register
An owner/operator of an establishment not exempt under 21 CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device intended for commercial distribution (marketing) is required to register. This includes manufacturers, contract manufacturers and contract sterilizers that place the device into commercial distribution, specification developers, repackagers or relabelers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose (that is, manufacturers of components or accessories that are intended to be sold or leased directly to the end user.)
An initial distributor (or importer) takes first title to the devices imported into the U.S. and further distributes the devices. Initial distributors/importers are required to register. However, they are NOT required to list the devices that they import.
Foreign establishments (manufacturers and exporters)
Foreign establishments that manufacture, prepare, propagate, compound, or process a device that is imported, or offered for import, into the U.S. are required to register their establishments. This includes contract manufacturers and contract sterilizers. Foreign establishments must also list the devices that they export to the U.S.
Definitions of establishment activities are provided below. Prior to registering your establishment, please review the definitions and determine what type of activities your establishment is performing. Please note that most establishments are also required to list their devices.
Please note that the following groups are not required to register:
- Wholesale distributors of devices who do not manufacturer, repackage, process or relabel a device. A "wholesale distributor" is defined as any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.
- Refurbishers and domestic distributors.
Establishment Registration Fee
The following types of establishments are required to pay the establishment registration fee to the US FDA:
- Device manufacturers Contract sterilizers Contract manufacturers Single-use device reprocessors Specification developers.
- US Agent for Foreign Establishments
- All foreign establishments must advise and notify FDA of the name, business name, address, phone number, and email address of their designated US Agent.
Responsibilities of US Agent
The responsibilities of the US Agent include:
- assisting FDA in communications with the foreign establishment,
- responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and
- assisting FDA in scheduling inspections of the foreign establishment.
If the FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US Agent, and such an action shall be considered equivalent to providing the same information or documents to the foreign establishment.
- The US agent has no responsibility to report adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or to submit Premarket Notifications [510(k)] (21 CFR Part 807, Subpart E)
- The US Agent must be designated at the time of electronic submission of establishment registration information.
When to Register
Domestic establishments must register within 30 days of the establishment entering into any activity requiring registration, including processing devices for exportation outside of the U.S. If you are required to list your devices, you must submit device listing information at the time of initial registration.
Foreign establishments must register, notify their US Agent, as well as list their devices prior to exporting to the U.S.
Your registration must be renewed annually each year. The registration period extends from October 1st through September 30th.
How to Register
In September, 2007, Section 207 of the Medical Device User Fee Modernization Act of 2002 (MDUFMA) amended section 510 of the Federal Food, Drug and Cosmetic Act (the Act) to require electronic submission of device registration and listing information unless FDA grants a waiver request. MDUFMA also authorizes FDA to collect a user fee for annual registration of certain types of establishments. Effective October 1, 2007, all establishment registrations are to be submitted electronically using FDA’s Unified Registration and Listing System (FURLS), unless a waiver has been granted by FDA.
If you are required to list your devices, you must submit that information at the same time as you submit establishment registration information. Establishments must register within 30 days after entering into any activity requiring registration or prior to importing or exporting a device.
Establishments must pay their establishment registration fee and receive notification from FDA that their payment has been received by December 31 of each year for their registration to be considered active and current for the fiscal year (October 1st through September 30th). It can take up to two weeks for your payment to be processed. You are not considered registered for the new fiscal year until FDA has notified you that your payment has been received.
Updating Registration Data
All registration information must be verified annually between October 1st and December 31st of each year. Establishments must pay their establishment registration fee by December 31 of each year for their registration to be considered active and current for the fiscal year (October 1st through September 30th).
Definitions of establishment activities
Manufactures a finished device to another establishment's specifications and places the device into commercial distribution. (Please note that contract manufacturers are also required to list their devices).
Provides a sterilization service for another establishment's devices and places the device into commercial distribution. (Please note that contract sterilizers are also required to list the devices sterilized at their establishment).
Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the U.S. A foreign exporter must have an establishment address outside the U.S.
Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance, safety, specifications, or in any way changes the intended use.
Repackager and / or Relabeler
Repackager: Packages finished devices from bulk or repackages devices made for the establishment by a manufacturer into different containers (excluding shipping containers).
Relabeler: Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Initial Distributor / Importer
Takes first title to devices imported into the United States. An initial distributor must have a U.S. address.
Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.
Reprocessor of Single-Use Devices
Performs remanufacturing operations on a single-use device.
U.S. Manufacturer of Export Only Devices
Manufactures medical devices that are not sold in the U.S. and are offered solely for export to foreign countries.
Frequently Asked Questions
How much does registration cost? Appropriate fees are charged annually.
How long is my registration valid? Each establishment registration is valid for one fiscal year. Firms must complete their annual registration establishment requirement each year for the registration to be valid.
Does registration or device listing fulfill my Premarket Notification 510(k) requirements? No. The establishment registration and device listing requirement is a separate requirement from the Premarket Notification 510(k) submission process. See Device Advice for information on how FDA regulates devices including how to submit a 510(k).
I am a distributor located outside the U.S. Do I have to register? Yes, foreign exporters must register their establishment, list the devices exported to the U.S., and identify the designated US Agent.
Are foreign dental and optical laboratories required to register and list? Yes, foreign dental and optical laboratories are required to register and list. They are not exempt from registration and listing. The exemption in 21 CFR 807.65(i) only applies to domestic establishments.
My establishment only does design work. Am I required to register the establishment? Company owned design facilities must register. That is, if a manufacturer owns a manufacturing facility and a separate facility for design work, both must register. Third party design facilities (design contractors) are not required to register. The manufacturer that contracts out the design work is responsible for maintaining the design control documentation in accordance with 21 CFR 820.30.
In addition to registration, foreign companies must also designate a qualified U.S. Agent.
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