A customs bond is required for medical device imports because they’re regulated by the FDA. In addition to registering with the FDA if required, you’ll also need to obtain a customs bond before importing. Not being registered despite being required to do so can cause serious issues when it’s time to import. Regardless, it’s worthwhile to verify whether or not you’re required to register with the FDA before importing medical devices. Component Manufacturer There are some exceptions to this.Some of the foreign entities that must register with the FDA include: The FDA views foreign establishments as unique and has separate criteria to determine registration requirements. In contrast, businesses like wholesale distributors, customs brokers, component manufacturers are not required to register with the FDA. Manufacturer of devices for export only.Some of the domestic establishments that are required to register with the FDA include: The most important detail that determines your FDA registration and listing responsibilities is the type of activity that you conduct in regards to the medical devices. ![]() Some entities may also be required to list all of the devices and activities performed. Instead, importers or other entities may be required to register with the FDA. It’s also important to note that there isn’t an “import license” when it comes to importing medical devices. Much of the confusion comes from the fact that there are many different entities- both foreign and domestic- involved in the production and distribution of medical devices. Ironically, it’s also one of the most confusing. This is one of the most frequently asked questions in regards to importing medical devices. ![]() If your shipment is non-compliant, we’ll go over exactly what needs to be done in order to bring it into compliance and successfully enter the U.S. Our team of licensed brokers can review the details of your shipment to ensure you’re in compliance.
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