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 imported into 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 weekly 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.