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FDA Medical Device Registration

All companies planning to sell a medical device or IVD in the United States need to register their product with the US FDA. If you are a Foreign Company exporting your medical device to the US, then you MUST, by law, have a US Agent.

Any medical device cannot be commercially distributed in the United States until it receives authorization from the FDA. We can get your device authorized and help you with Device classification, pre-market notification, device registration, labelling and much more.

Find out more below or get in touch with us today for a free consultation by filling out our form.

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U.S. FDA Medical Devices Establishment Registration and Device Listing

The United States remains the largest medical device market in the world: $156 billion (40 percent of the global medical device market in 2017). However, to access this market, you MUST ensure your device meets all FDA requirements.

As stated by the FDA “Section 201(h) of the Food, Drug & Cosmetic Act. (FD&C Act) defines a device as: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar. or related article, including a component part or accessory.

Any medical device establishments that develop, manufacture, pack, assemble, label, export or import medical devices are required to Register with the U.S. Food and Drug Administration (FDA), and pay an annual FDA user fee that of 5,672 USD for the year 2022.

How We Can Help

    Global import Agent can act as your US FDA Agent for medical device registration and listing and help you along every step in the process. We can help through:
  • Identification of device and classification into either Class I, Class II, Class III or if your device is 510k or explore any exemption reasons.
  • Gather company information, assist in getting a DUN’S number and ensure all information is correct.
  • Creation of FDA payment account and assistance in submitting annual user fees.
  • Ensure device establishment registration and device listing is done correctly so that no problems arise in the future.
  • Provide an FDA Approved certificate and handle any future registration and listing inquires.
  • Ensure that your device is correctly labelled and meets all US FDA Regulations.

Why do I need a US Agent?

The U.S. agent will be required to speak with the FDA regarding the foreign registered facility. As a result, it is crucial that the U.S. agent understands the FDA regulations and can advise the foreign establishment on FDA medical device requirements that must be followed. Having an independent U.S. agent will ensure clarity on all FDA requirements and avoid any potential detentions or refusals.

Global Import Agent provides FDA medical devices establishment registration and medical device Listing and can act as U.S. FDA Agent to Non-US companies that are already in the market or intending to enter the U.S. market.

Why Choose Global Import Agent?

Global Import Agent is an affordable, state of the art solution that brings cloud technology together with a global network of qualified, vetted, multi-lingual medical device experts to ensure that you are FDA approved for the USA Market.

All our consultants are previous FDA employees who specialise in medical devices, meaning that we can offer clear, up to date guidance on your specific product and the requirements you must meet.

We work with our clients to ensure they understand the process and their importing journey is problem-free. Contact us for a quotation, we think you will be pleasantly surprised by how affordable and comprehensive our service is.