Your how to guide on medical devices, bandages, masks, wheelchairs, ventilators and the like into the United States
If you are importing medical devices such as ventilators, bandages, face masks, wheelchairs, stethoscopes, hospital beds and the like into the United States, you must know what government parties are involved, what regulations must be followed, and the fundamental aspects of medical supply imports.
If you are importing medical devices due to the COVID-19 Global Pandemic, please review US FDA's notice on importing.
If you are importing medical supplies into Canada, please visit How To Import Medical Supplies Into Canada.
- All items imported into the United States must follow the guidelines of the Food, Drug and Cosmetic Act and Medical Devices Regulations.
- FDA categories medical devices into one of three classes, from lowest risk (Class 1) to highest (Class 3). Refer to the Product Classification database to find out into which class your imports fall.
- There are certain labeling, marketing authorization requirements.
- Commercial importers may be required to obtain a Establishment Licence, Site Licence or Establishment Registration; or authorization to conduct a clinical trial.
- Importers must follow the Medical Device Good Manufacturing Practices as defined in the Food, Drug and Cosmetics Act.
- The Food, Drug, and Cosmetic 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 which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
- which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions specifically excluded by the regulations.
- You will be acting as the Importer of Record. Therefore, you are the party ultimately responsible for the accuracy and completeness of the import declaration; as well as, the payment of applicable duties and taxes into the United States.
- Duty and fees must be paid upon importation into the United States.
- The rate of duty this link is for vehicle exports and does not make sense in this document is determined by
- The tariff of the commodity being imported
- The value of the goods
- The origin of the goods
- Certain import documentation is required to be presented to the border services officer at the port of entry.
- Your import may be subject to a customs review, inspection or audit prior to, or after the importation. Additional fees may be levied by the Government of the United States for these services.
- You are required to keep your import records for five years following the date of import and can be audited by Customs at any point during this time.
FAQ: Medical Device Imports
What are the labeling requirements for medical devices imported into the US?
For some goods such as Investigational Testing devices to be used on human subjects and Special Access and Custom-made devices require special labeling. Contact us for more information.
What additional information is required to import Medical Devices?
- Intended Use Code
- Country of Production
- Name and Address of Device Initial Importer
- Affirmation of Compliance Codes
What is an Affirmation of Compliance Code?
Affirmation of Compliance Codes are codes used to provide additional information to FDA in regard to the medical device or drug being imported. A few examples of mandatory Affirmations of Compliance codes required for the import of medical devices or drugs are listed below:
- DEV - Device Foreign Manufacturer Registration Number
- DFE - Device Foreign Exporter Registration Number
- LST - Device Listing Number
- PM# - Premarket Approval/Notification Number - Conditional
- DLS - Drug Listing Number
- REG - Drug Registration Number
Contact us for more information specific to your medical device