If you are based in the United States and import medical devices, FDA requires you to be registered as an Initial Distributor. Regulatory Insight has registered many importers of medical devices with the FDA and can register your company with the FDA as an Initial Distributor as well.
If your company is based outside the U.S. and your medical devices are being exported to the United States, your company must also be registered with the FDA as a manufacturer, foreign exporter or other type of establishment, as applicable. You must also list your devices with the FDA, and you must assign someone residing in the United States to act as your company’s U.S. Agent (please see our U.S. Agent Page). Regulatory Insight can register your company, list your devices with the FDA, and act as your company’s U.S. Agent.
Sometimes, U.S. Customs or the FDA Import Office may place a hold on the devices you are trying to have imported into the U.S. This may be due to problems with your company registration, product listing or some other issue. Regulatory Insight effectively resolves such problems on a routine basis for our clients. We will work with U.S. Customs or the FDA Import Office to resolve the outstanding issue and release your company’s medical devices from hold in as timely a manner as possible.
If you are a U.S. manufacturer and wish to export your products outside the United States, Regulatory Insight can assist your company to meet applicable regulatory agency requirements.
Many companies outside the United States are also required by their local governments to obtain a Certificate to Foreign Governments (i.e. Export Certificate) before they can purchase products from a U.S. manufacturer. Regulatory Insight can quickly obtain an Export Certificate for your company so you can fulfill your international customer orders.
FDA’s 21 CFR 807.40(b) states “Each foreign establishment required to register under paragraph (a) of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with subpart B of this part. Each foreign establishment shall designate only one United States agent and may designate the United States agent to act as its official correspondent.”
Therefore, if your company is located outside the United States and you wish to have your product imported into the U.S., you must designate someone residing in the United States to act as your company’s U.S. Agent for FDA matters.
Regulatory Insight is currently the U.S. Agent for more than 100 companies located outside the United States. We do not charge a recurring annual fee to act as a U.S. Agent, as many consulting companies do; rather we only charge for services rendered as your U.S. Agent. We would be delighted to serve as your company’s U.S. Agent.