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US Agent

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.

Medical Device Listing

All medical devices that are manufactured and imported into the U.S. are required to be listed with the FDA. Firms that are required to list their devices are those that:

• manufacture
• repackage and relabel
• develop specifications
• reprocess single-use devices
• remanufacture
• manufacture accessories and components sold directly to the end user

A separate device listing form must be submitted for each type of device.

Medical Device Listing as required by the US FDA to export your product to the USA

What Is Medical Device Listing

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as 'medical device listing' and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing. The regulations for medical device listing are provided in 21 CFR 807.

Each generic category is represented by a separate classification regulation found in Title 21 Code of Federal Regulations Parts 862-892 or FDA assigned device name. Each regulation number or device name is associated with one or more product codes. Regulation numbers with more than one product code identifies the product in further detail. For example, "Manual Surgical Instruments for General Use," 21 CFR 878.4800, contains several product codes including GAB (disposable suturing needle), GDX (scalpel), HTD (forceps) and HRQ (hemostat).

Listing of a medical device is not approval of the establishment or a device by FDA. Unless exempt, premarketing clearance is required before a device can be marketed (placed into commercial distribution) in the U.S.

All device types classified as exempt from the Premarket Notification 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx is replaced with Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware that it is your responsibility to ensure that you meet the exemption criteria and that your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.

While there is no separate fee for listing your device, device listing is completed as part of the annual registration process. Many device establishment types are subject to an annual registration fee.

Who Must List

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 list its device with FDA within 30 days of entering the device into commercial distribution in the U.S. This includes manufacturers, repackagers and relabelers, specification developers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of accessories and components 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.) (21 CFR 807.20). Foreign manufacturers and foreign exporters must list their devices prior to importing into the U.S.

Domestic contract manufacturers and contract sterilizers are required to register their establishment and list their devices if they commercially distribute the devices. Initial importers located in the U.S. are required to register their establishment; they are not, at this time, required to list their devices.

The following establishment types are required to list their devices:

Contract Manufacturer

Manufactures a finished device to another establishment's specifications and places the device into commercial distribution.

Contract Sterilizer

Provides a sterilization service for another establishment's devices and places the device into commercial distribution.

Manufacturer

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.

Remanufacturer

Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or 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.

Specification Developer

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.

Foreign Exporter

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.

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.

Note: Initial distributors (importers) located in the U.S. are not required to list their devices. However, they are required to register their establishment. Refurbishers and domestic distributors are not required to list their devices or register their establishment.

When to List

When an owner/operator of a domestic establishment enters into an activity that requires registration, device listing much be completed at the time of registration for the establishments that are required to list as discussed above under "Who Must List."

The owner/operator must also submit a device listing when it introduces a device into commercial distribution that has a classification name or product code that is not currently listed.

Foreign establishments must to submit device listings prior to exporting their devices to the United States. Registered establishments are also required to review and update their listing information once per year, during the registration period of October 1st to December 31st of each year. You can update your device listing(s) at any time. We encourage you to update your device listings at time the change occurs.

Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles

Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the Food and Drug Administration (FDA). Although these devices are 510(k) exempt, several other FDA regulations apply:

• U.S. manufacturers and initial U.S. distributors (importer) must register their establishment with FDA;
• foreign manufacturers must register their establishment with FDA and name a United States Agent;
• manufacturers must list their device with FDA.
• manufacturers must meet Quality System (QS) requirements,
• the lens for spectacles and/or sunglasses must be certified as impact resistant.

How to List

All listing information (new, updates or annual review) must be submitted electronically unless FDA grants you a waiver. Electronic registration and listing is completed through FDA’s United Registration and Listing System (FURLS).

Updating Listing Data The official correspondent of each establishment is responsible for keeping their listing records current. You can update your device listing(s) at any time through FURLS.

The owner/operator must submit a device listing when it introduces a device into commercial distribution that has a classification name or product code that is not currently listed. We encourage you to update your device listings at time the change occurs. Updating is required when one of the following occurs: All models or variations of a listed device is removed from commercial distribution. That is, the product is discontinued. The commercial distribution of a previously-discontinued device is resumed. There is a change in the type of activity performed on a device, such as where it is being manufactured. You are encouraged to identify proprietary names or trade names to distinguish various models of the same device.

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