Every year, hundreds of thousands of medical devices are imported into the U.S. These imported devices are essential in meeting the demand for the U.S. healthcare market. At the same time, CBP, with the help of the FDA, seize many devices that don’t meet import and/or market requirements. In order to safely bring your medical devices into the U.S., you’ll need to strictly adhere to all of the rules and regulations.
To import medical devices into the U.S. the FDA and CBP require specific information upon entry. This information includes:
Failing to provide any of the required information upon entry can result in products being permanently detained by CBP.
Before importing medical devices into the U.S., it’s advisable to consult with a Licensed Customs Broker. Our team of licensed brokers can review the details of your shipment to ensure you’re in compliance. 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.
For a detailed breakdown of the process of importing medical devices into the U.S., read through the detailed guide below.
This is one of the most frequently asked questions in regards to importing medical devices. Ironically, it’s also one of the most confusing. 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.
It’s also important to note that there isn’t an “import license” when it comes to importing medical devices. Instead, importers or other entities may be required to register with the FDA. Some entities may also be required to list all of the devices and activities performed. 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 of the domestic establishments that are required to register with the FDA include:
In contrast, businesses like wholesale distributors, customs brokers, component manufacturers are not required to register with the FDA.
The FDA views foreign establishments as unique and has separate criteria to determine registration requirements.
Some of the foreign entities that must register with the FDA include:
Regardless, it’s worthwhile to verify whether or not you’re required to register with the FDA before importing medical devices. Not being registered despite being required to do so can cause serious issues when it’s time to import.
In addition to registering with the FDA if required, you’ll also need to obtain a customs bond before importing. A customs bond is required for medical device imports because they’re regulated by the FDA. Import customs bond can be either a single entry bond or continuous. We offer continuous customs bonds which allow you to cover all of your shipments for one full year from the date that the bond is issued.
Along with some of the requirements mentioned above, the FDA may require additional information and documentation when importing. Many of these requirements exist in documentation that must be provided to CBP at the time of entry.
Below we explore some of the major FDA import requirements.
Premarket Notification (510k) Or Premarket Approval
Depending on the device, one of these premarket confirmations will be required. Both of these extensive documents are designed to ensure that devices meet specific FDA standards before entering the U.S. market. Proof of approval from the FDA will be required at the time of import.
Establishment Registration and Device Listing
This requirement was covered in the previous section and must also be provided at entry.
All medical devices coming into the U.S. are required to meet certain FDA labeling standards.
Labeling standards include:
Some devices such as condoms, hearing, and eyeglasses must meet additional labeling requirements
Medical Device Reporting
FDA must have access to past reports of complaints regarding any medical device. Devices deemed to be unsafe will be denied entry.
Medical Device Tracking
Some devices are required to be physically tracked from manufacture through consumer use. This only applies to certain class 2 and 3 medical devices.
It’s important to remember that these FDA requirements are in addition to standard CBP rules when importing. With so many opportunities for things to go wrong, it’s best to partner with a reliable expert that can make sure everything is in order. Our team of licensed professionals at USA Customs Clearance have worked closely with many importers of FDA regulated products. We’ve simplified the import process for our partners and can do the same for you.
To learn more about the complete process for importing FDA regulated products, check out our article on FDA Customs Clearance.
The duties on imported medical devices vary based on a number of different factors. First, there are countless different types of medical devices and each has their own unique HTS code. Many devices even have multiple codes depending on product features such as component materials, size, and more. Second, the country of origin where the finished device was manufactured is an important aspect. For example, a thermometer from China will have a different import duty than one from Mexico.
Thankfully, the U.S. sees the value in high-quality imported medical devices and in turn assesses a 0% import duty on many devices. However, some devices are still assessed an import duty, typically ranging from 2-6%. Some medical devices from China are currently being hit with additional duties due to the Section 301 act.
Regardless of whether your device is subject to import duties or not, it will still need to be classified with the correct HTS code. Classifying your product with the wrong code will lead to additional inspections and possible fees from CBP.
During our customs consulting sessions, our brokers can provide you with the correct product code for your device. This ensures that your shipment will clear customs quicker and with less scrutiny.
It is important to note that there are three main classes of medical devices. The FDA under the U.S. Food, Drug, and Cosmetic Act demands that all medical devices must pass all FDA regulations before being allowed for importation into the country to ensure safety and effectiveness. This is to reiterate that any establishment looking to bring in clinical gadgets from outside manufacturers and distributors ought to know that the FDA does not recognize regulatory endorsements from foreign nations.
The classification of a device is based on a number of factors including its intended use and also indications for use. The class to which your device is consigned decides, in addition to other things, the sort of premarketing accommodation/application required for FDA leeway to advertise.
Class I devices are subjected to what has been termed "general control.” Most medical devices in this category may enter the United States essentially by ensuring that their naming conforms to the FDA guidelines. Class I devices are not proposed to help life or draw out life or be fundamentally significant in forestalling injury to human wellbeing. Examples of class I devices consist of bandages, assessment gloves, and hand-held clinical instruments.
This class of devices conveys a higher risk than those in class I. A defective class II device may cause harm and injury to consumers when found faulty. This classification of a medical device must meet general controls as well as special controls. Although some class II devices are excluded from the premarket announcement, special control may consist of performance guidelines, labeling requirements, and post-market surveillance.
Post-market surveillance (PMS) is described as a 'system that provides continuous feedback about a device on the market to maintain a high standard of product quality.’ PMS is an administrative requirement in significant business sectors like Europe and the United States. The surveillance system can be used to deny or verify the safety of devices and drugs after being used by a large population of people with various health conditions.
Some examples of class II medical devices include:
Devices in Class II are held to a more significant level of affirmation than class I devices as they are intended to proceed as demonstrated without causing injury or damage to patient or client
Devices fall under this classification when there is not adequate information to ensure the overall safety and effectiveness for them to be categorized under Class I or Class II. Such devices require premarket validation, a rational way to guarantee the devices wellbeing and efficacy, and possesses the overall controls of Class I. Class III devices are generally meant to support or extend human life, are critical in forestalling injury of human wellbeing, or reduce the chances of avoidable risk of injury. Examples of Class III devices are breast implants, pacemakers, defibrillators, high-frequency ventilators, and HIV diagnostic tests, as they require premarket notification.
The vast majority of products, especially medical devices, are noted to be imported from China to the United States. But recent poor trade relations between the United States and China have adversely impacted this. The trade relations reached a peak in the form of the Section 301 tariffs. These tariffs covered nearly every product going from China to the U.S. including many medical devices. Worse yet, these additional tariffs are as high as 25% in some cases.
While some products have been granted a section 301 exclusion, many are still being assessed an additional tariff. Before importing medical devices from China, it’s wise to consult with our team. Due to the rocky trade relations between the U.S. and China, CBP has been applying extra scrutiny to imports from China. No need to worry though as our team has extensive experience. We’ve even recovered millions in section 301 duty drawbacks for our clients through various methods.
The Food and Drug Administration is mandated to ensure that all imports that fall under their jurisdiction have complied with laid down FDA laws and regulations. They also ensure import compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). No individual or company can engage in the sale of medical devices in the United States without the approval of the FDA. They must present all proof that the device is safe and can be used for a specific purpose.
During the customs clearance process for medical devices, your import may go through various FDA customs holds. To better understand the different types of holds/exams, we can examine them in detail below.
FDA is approved to inspect and gather tests of FDA-controlled items offered for import into the U.S. If the FDA chooses to inspect or test your products, a Notice of FDA Action will be given to the importer of record, consignee, and filer. It is your obligation to advise the FDA office taking care of your arrival that your items are available for assessment. The FDA office taking care of your entry is recognized on the Notice of FDA Action.
When the area of your item is given, the FDA will proceed to analyze the items. Items pending FDA assessment or test assortment must be held and ought not to be dispersed into the business until results are assessed, and the items are delivered. The inability to store your items may bring about FDA ordering Customs and Border Protection (CBP) to request redelivery.
On the off chance that the imported device appears to be in violation of any import requirements, the device will be temporarily detained. FDA will provide a notice of action along with specific details of the suspected violation. The importer will then have a chance to offer evidence in opposition to the violation within a defined period.
This is issued when there is enough proof or other information available to FDA personnel to allow for Detention Without Physical Examination (DWPE) of products focused on an import alert. Items are liable to DWPE dependent on past infringement. These infringements could be identified with the product, manufacturer, transporter as well as other data showing the item might be disregarding FDA laws.
FDA-regulated items can be denied admittance to the U.S. in the event that they don't comply with the FDA's laws and guidelines. The motive behind such could be the labels containing false information, unapproved new drugs, items restricted for sale in the U.S., and products that are contaminated and, therefore, unsafe for use. All these do not meet the required standards. In August 2020 alone, there were over 1,000 unique FDA regulated goods that were denied entry into the U.S.
These are regular assessments carried out on filer entries to ensure that they’re being submitted accurately. Filer evaluations can take place during or after an import takes place. Importers will only be notified if an entry is found to contain errors.
While importers aren’t required to work with a customs broker, it’s highly recommended due to the risk involved with importing FDA regulated products. There are many points in the import process where things can go wrong and mistakes can completely derail an import. Customs brokers work directly with importers to ensure that these mistakes don’t occur.
Our team of U.S. Customs Brokers carefully examine every detail of your shipment to ensure it will safely clear customs.
As you can see, importing medical devices into the U.S. can be quite a challenge. Thankfully, you don’t have to tackle it alone. With our experienced and knowledgeable team, by your side, you’ll have the support you need.
We’ll provide you with critical information and assistance every step of the way. If you just need information to get the job done yourself, schedule a customs consulting session with one of our Licensed Customs Brokers. They’ll answer all of your questions and provide you with everything you need.
Need more help? We’ve got you covered. Our complete range of customs brokerage services enables us to handle the entire importing process for you. From ISF Filing to duty drawback and more, we can serve as your one-stop shop for all of your importing and transportation needs.