At MDCI, we have recently run across a number of cases where companies who have been importing medical devices into the United States for years suddenly encounter issues at U.S. Customs. In some cases, companies are not even aware that their products are regulated as medical devices by the FDA. In others, shipments of medical devices are denied entry into the country for a variety of different reasons, with the most common being a lack of data required for the FDA to determine the admissibility of a particular product.
These are not isolated incidents, and point towards increased scrutiny being directed at imported medical devices by federal regulators. In fact, the FDA has published a “Letter to Industry” discussing a voluntary import entry review process in order to clear up some of the confusion surrounding what appear to be stricter policies at the border.
In actual fact, import regulations for medical devices have not changed. What appears to have happened is that the FDA has become stricter about enforcing existing policies. In its open letter, the FDA references several aspects of the admissibility process that it feels will help medical device companies skirt problems at U.S. Customs.
One of the first recommendations made by the FDA is that importers ensure that all products are bundled along with their respective Affirmations of Compliance (AofC) containing all of the information required for selling a medical device in the United States. AofC codes are required for the following, taken directly from the FDA letter:
- Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
- Device Listing (LST)
- Device Initial Importer (DII)
- Premarket Application (PMA) (Can be a PMA, a Humanitarian Device Exemption (HDE), or a Product Development Protocol (PDP) number), OR a Premarket Notification Number (PMN), OR an Investigational Device Exemption (IDE)
It’s important to understand that these AofC codes are not mandatory, but rather provide a method for ensuring that medical devices avoid being held for additional FDA entry review. It is also important to note that there is no standardized form or format for AofC, and the history of the success of AofC information is not yet known. FDA entry review is performed manually, line-by-line, which can add significant delays to the importation process. In addition to providing AofC codes, it goes without saying that clear and accurate shipment documentation should accompany all medical devices entering the United States.
Another method for ensuring ease of import entry for medical devices is called the Prior Notice program. Prior Notice consists of (but is not limited to) the following data that must be electronically provided to the FDA prior to the arrival of the article(s) at the first U.S. port:
- The country from which the article originates
- The country from which the article is shipped
- CBP ACS entry type and date
- In the event of a hold, the information about where it is being held
- Firm name and address
- E-mail address
- Telephone and fax numbers
- Registration number
- Standard carrier abbreviation code
- Anticipated CBP port of arrival
- All carriers
Time of filing of the information with CBP depends on the mode of transportation.
A little time invested early on at the export stage can make a huge difference in avoiding hassles further down the line when it comes to importing medical devices.
Rosina Robinson
Benjamin Hunting
MDCI Blogging Team
Just a question. As i understand it, to get the goods into the US the device meeds 510k cleearance and the Establishment and device listing registration is required. does everyone involved need to register? For example, if the foreign manufacturer themselves are not registered as an establishment, would the registration of a Distributor/Exporters establishment and the class ii device (510k cleared) be acceptable? Thats if the exporter changes the label etc
Or does everyone need to be registered and pay the fee?
To import medical devices into the US, a 510(k) number, premarket application number OR an investigational device exemption number is required as the blog post states. The Establishment and Device Listing registration is not required for all foreign establishments that are involved with the medical device. For a listing of those who must register and pay a fee, please review the FDA website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm#domestic.
For instance, foreign manufactures of the final finished device as well as foreign exporters must register, list and pay the fee. Domestic distributors are not obligated.
New 2013 requirements for registration and listing can be found here: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm.
A schedule of the fees can be found here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm.
For more information regarding this topic, please see our September 24, 2012 blog post “FDA Makes Changes to Registration and Listing Requirements for Medical Devices” here: http://www.aptivsolutions.com/blog/medical-device/2012/09/fda-makes-changes-to-registration-and-listing-requirements-for-medical-devices/