Exporting Medical Devices from the US: Complying with FDA

March 12, 2024
 By Jacob Lee
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Exporting Medical Devices from the US: Complying with FDA
Last Modified: March 12, 2024
If you’re not sure how to export medical devices from the U.S., we’ve got you covered. Our guide has all the information that will help you ensure your shipments are always a success.

Certificates can be obtained from the Food and Drug Administration (FDA) for medical devices that are exported overseas. Sellers of these products will have to pay applicable fees for their certificates.  Exporters also need to follow strict record keeping requirements after they’ve sent their equipment to a foreign nation.

Exporting medical devices from the U.S. can be a complex process, but with our guide, you’ll learn everything you’ll need to ensure your shipments are smooth and successful.  

Container ships being loaded full of medical devices

What Certificates Are Required for Exporting Medical Devices from the U.S.?

The FDA doesn’t explicitly require medical device export certificates for compliance purposes. That said, foreign buyers and governments that purchase these goods from the U.S. often want proof the items they’re receiving are FDA approved. 

Documents that provide that proof also give you, as the exporter, a bit of additional information. 

  • Information on the marketing or regulatory status of each item
  • Written verification that the product meets a specific set of requirements
  • Data on radiation emission, when applicable, to be used by the seller   

The Center for Devices and Radiological Health, or CDRH, is the organization responsible for giving certificates for anything emitting radiation.. We’ll go through the details of each document and explain what criteria is necessary to use each one. 

Certificate to Foreign Government

A CFG is a medical device export certificate that’s used for items that can be legally marketed in the U.S. and that abide by the Food, Drug, and Cosmetic (FD&C) Act guidelines. 

The FDA doesn’t need to give approval or require notification when these goods are sent to another country.  However, they are good for exporters to have as proof that a standard was used during the manufacturing process. 

Nations where you may need to provide a CFG to local importers include:

  • China
  • India
  • Brazil
  • Argentina
  • Saudi Arabia
  • United Arab Emirates (UAE)

To make sure you stay compliant, the best thing to do before exporting will be to check with the local import laws of the destination country. This is especially true in emerging markets where import rules can often change with very little notice. 

It should be noted that the European Union does not require CFG, but only because it has its own regulatory body for medical devices. We’ll provide more information on this later on.

Certificate of Exportability 

These certificates are issued for exported goods that aren’t legally marketed in the U.S., but still meet FD&C Act requirements. 

There are two sections of this Act that we will examine more closely with regard to this certificate. 

  1. Section 801 (e)(1)

Devices in this section fall under Class I and Class II specifications. 

Class I devices can be shipped out without permission from the FDA. These devices are low-risk items, which typically include products like bandages and nonelectric wheelchairs. 

Class II devices are intermediate-risk goods, like infusion pumps for medications. However, they can be exported without FDA permission so long as:

  • Products aren’t in conflict with the destination country’s requirements
  • Goods are labeled as intended for export on the packaging
  • Items aren’t sold or offered for sale in the U.S.
  • Goods are in accordance with specifications made by the buyer

Other specific requirements of Section 801 (e)(1) include the following: 

  • Items must be in accordance with the foreign purchaser’s specifications
  • Devices should be labeled as intended for export outside the shipping package
  • Exported products cannot conflict with laws of the country it’s being shipped
  • Sale is not permitted for the goods in the U.S.
  1. Section 802

Some class II as well as Class III products fall under this section. A Class III device is high-risk, which typically means that it’s  used to sustain life. This can include products such as:

  • Implantable cardiac defibrillators
  • Pacemakers
  • Mechanical heart vales

The requirements for Section 802 devices to be exported include the following:

  • Devices should be in conformance with the Quality System regulation or meet an international quality standard that’s recognized by the FDA
  • Medical equipment exports from the USA must be unadulterated 
  • Medical devices shouldn’t be the subject of a notice by the Department of Health and Human Services stating they could pose a hazard if re-importation were to occur, nor pose a hazard to the exporting country
  • Medical equipment must not be mislabeled

Devices that are shipped with a Certificate of Exportability should still comply with all laws regarding the import of medical supplies and equipment in the receiving country. 

They will also need to have valid marketing authorization by the correct authority if the destination is a Tier 1 country as outlined  in Section 802. 

Tier 1 countries include:

  • New Zealand
  • Australia
  • Canada
  • Switzerland
  • Israel
  • South Africa
  • Japan
  • European Union (EU)
  • Country in the European Economic Area 

Other circumstances where Section 802 of the FD&C Act applies:

  • Devices intended for treatment of diseases not prevalent in the U.S.
  • Devices are exported for investigational use
  • Exported devices intended for further processing

As the criteria shows, there are many instances where it will be appropriate to use this document. Always carefully review and classify your products beforehand to make sure you are following the right set of requirements.

Non-Clinical Research Use Only Certificate

An NCR is used for the export of non-clinical research items that are meant for human use.

This can include:

  • Products
  • Materials
  • Components 

These items can be legally marketed and shipped to another nation under the FD&C Act. 

Before you export, make sure you learn about Schedule B Numbers and include them in your shipment. 

CE Marking Application

If you’re exporting medical devices to the European Union, you’ll need a Conformite Europeenne (CE) mark. There are four steps that have to be followed to obtain the CE mark

  1. Conformity Assessment
  2. Create Technical File
  3. Affix CE Marking Label
  4. Draw Up EU Declaration of Conformity

In some cases, an exporter can perform a conformity assessment that proves their medical device is in line with CE directives. Conformity assessments like these require strict adherence to EU standards and testing by an independent lab that certify compliance. 

Directives that allow for self certification include:

  • Safety of machinery
  • Electromagnetic compatibility
  • Low voltage

Other EU medical device directives will require testing from a designated lab that’s connected with a European Notified Body, which is an organization designated by an EU member state. This will apply to products that pose a high risk to safety. Labs in the U.S. subcontract this work and can perform testing. 

Next, a technical file will need to be created. This includes information like product test reports and certificates. It must be available for 10 years after the product is put on the market. Next, the CE mark will need to be placed on the product near the manufacturer’s nameplate.

Finally, a Declaration of Conformity must be provided. This is essentially a statement from the manufacturer that allows EU buyers to import and circulate the products throughout the market. 

Heart monitoring equipment that's used in hospitals

How Can Exporters Authenticate Their Export Certificates?

Foreign buyers may want to authenticate the export certificates that come with their medical devices. As the seller, you can direct customers to a few institutions that will help them determine the validity of these documents. 

FDA Unified Registration and Listing Systems

The Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) is an authentication resource. 

Foreign buyers will be able to find the following information about their certificate in the database:

  • Establishment name
  • Certification type
  • Expiration date
  • Certificate numbers
  • Number of pages per certificate
  • Image of certificate

Directing your buyers to such sources can help build trust and promote further sales

CDRH Export Certificate Validation Database

Another way documents can be authenticated is by using the CDRH’s Export Certificate Validation (CECV) database.

It’s updated once a week and is used to validate any document that’s been issued by the CDRH. The CECV database provides all the same information on the certificate as the FECV, except for an image of the document. 

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Where Can Exporters Request Certificates and Permits for Medical Equipment Exports?

The Certification Application and Tracking System (CECATS) is where exporters can obtain their certificates. The documents will appear in PDF form and be made available for download. Sellers will also use CECATS to submit requests for export documents. 

Benefits of using this system include:

  • Reduced certificate processing
  • Real-time validation
  • Status updates of the request 

As an export businesses, you would be allowed to make changes to your application before it’s reviewed. You can also upload any additional information that’s needed for their request. 

To submit an application through CECATS, follow these steps:

  • Log into CECATS account using account ID and password
  • Exporters will be asked if their goods are being exported from the U.S. and after answering yes, they’ll be redirected to the home screen
  • Exporters will then pick the certificate they wish to obtain

Each certificate has a different application process. CECATS provides detailed instructions for the documents that exporters can utilize. 

How Much Does An FDA Medical Export License Cost?

The FDA charges exporters a fee for each medical device certificate. After submitting a request, you’ll typically receive an estimate for the charges. We’ve created some data on the fees to  expect. 

Medical Export Certificate Fees

Type of FeeFee Amount
Fee for First Certificate$175
Fee for Subsequent Certificates from Same Request$85

Provided by FDA

To break this down, the first certificate an exporter submits a request for will be $175. If you must obtain additional certificates for the same medical devices, the subsequent documents will be $85. 

Each downloadable PDF of the document is no longer than 25 pages. Exporters can request as many copies of their certificates as they want. That said, every additional 25 pages will cost another $175. 

In practice, this affects what you pay based on how long a particular certificate may be and how many copies you need. Some are 5 pages long, others may be 15 pages long. It often depends on how many product attachment pages are added in. Since the number is rounded up by the FDA, you end up paying for 25 pages at a time while ALSO being charged for the copies at the $85 rate if needed.

For example, five copies of a 15-page certificate, require a total of 75 pages. If each group of 25 pages is $175, you’re looking at a total of $695 once you add the fee of the additional copies.

  • 15-pages x 5 copies = 75 pages
  • 75 pages / 25 = 3 original certificates
  • 3 Original Certificates x $175 fee = $525
  • 5 copies needed – 3 originals already calculated = 2 additional to calculate
  • 2 certificates x $85 subsequent fee = $170
  • $525 (covers 3 certificates) + $170 (2 additional certificates) = $695

In this example, you’re only charged $85 for the two certificates that aren’t covered by the extra paper charge. If those five copies had only been 5 pages long, and therefore only needed the initial 25 pages that are covered by the original fee, the amount owed would be different. One original certificate at $175 plus 4 subsequent copies at $85 (4 x 85 = 340) each for a total of $515. 

Bottom line, you pay for originals and you pay for copies. How much will depend on how many pages they fit on. 

Stacks of FDA paperwork used for clearing medical devices

Record Keeping Requirements for Exporting Medical Devices

There are certain record keeping requirements for medical devices that the FDA wants exporters to follow. These fall under Sections 801 (e)(1) and Section 802, which we discussed earlier in regard to Certificates of Exportability. Just like with the certificates, record keeping demands differ. 

For medical devices subject to Section 801(e)(1), exporters should follow these requirements when choosing which records to keep: 

  • Records that demonstrate the product meets the specifications of a foreign purchaser must be kept
  • Records that  show goods don’t violate the laws of the destination country
  • Records showing the product’s package is labeled correctly
  • Proof the medical device hasn’t been sold or offered for sale in the United States

To show a product meets foreign purchaser specifications, exporters can use two types of documentation. 

  1. A letter from an appropriate government agency, department, or authorized body that states the product can be marketed or doesn’t conflict with any laws.
  2. Notarized certification by a responsible company in the United States that shows the product doesn’t conflict with any laws in the foreign country. 

Records that prove a shipping package for a medical device was labeled correctly can come in the form of label copies or statements. Exporters can use production and shipping records to show the goods weren’t offered for sale in the United States. 

For medical devices under Section 802 of the FD&C Act, keep records on the following: 

  • Device trade name
  • Type of device
  • Device model number
  • Consignee name and address
  • Date of when the device was exported
  • Amount of devices exported

Records for these exported goods have to be kept for the same period of time the device has been made to last. As a general rule, records must be kept for at least two years after the release of the items for commercial distribution by the manufacturer. 

Make sure you’re an exporter of record before you start shipping medical devices to another country. 

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How To Export Medical Equipment Not Made In the U.S.

There’s no rule that says U.S. exporters can only work with products made in the USA. However, foreign-made medical devices will need to be accompanied by a unique export certificate. As far as fees are concerned, expect the same pricing structure for this document. 

CFG-NE 

Some medical equipment is made outside the borders of the United States. For these products,  a Certificate to Foreign Government for Device Not Exported from the U.S. (CFG-NE) is needed. This document could be used for goods that were produced at a nearshore operation in Mexico. 

The document can also be applied to foreign made equipment if it’s cleared, approved, or a premarket report isn’t needed. Exporters can validate the legitimacy of their CFG-NE using the FECV and the CECV we’ve mentioned prior. 

CFG-NE Application

As with the other certificates, exporters can apply for CFG-NE using the CECATS system. After signing in to the account, answer “no” when asked if the goods will be exported from the United States. From here, users will be sent to the CFG-NE application. 

To submit a request for a CFG-NE, exporters will need the following:

  • Owner, operator, or FDA establishment registration number for the manufacturer
  • Marketing status with the date of approval/clearance and the product code
  • Device list

When applying for the CFG-NE, sellers should also fill out a Form 3613g. This document is essentially supplementary information that will assist exporters in obtaining their certificate.  

Hospital beds in a sterile warehouse

What Other Documentation Is Needed for U.S. Medical Exports?

Often times, sellers won’t need any additional documentation other than a certificate when shipping off medical devices. That said, there are a few instances where the FDA must be notified when certain medical devices are exported to another country. 

Exporters will need to use one of the following documents to notify the FDA:

  • Export Permit Letter Under Section 801(e)(2) or 802(c) of the FD&C Act
  • Simple Notification

The Export Permit Letter Under Section 801(e)(2) can be used for the following types of medical devices:

  • Class III investigational devices
  • Banned devices
  • Unapproved devices that haven’t been submitted for Premarket Approval (PMA) and that don’t meet criteria under Section 801(e)(1) to earn a Certificate of Exportability

The FDA will need notification if unapproved medical devices are shipped to a country that isn’t listed in Section 802(b)(1)(A)(i) and (ii). In such a case, goods will need an Export Permit Letter Under Section 802(c) of the FD&C Act.

Equipment exported using a Section 802(c)  permit will need to meet the following requirements:

  • Medical devices will need to abide by the regulations of Section 801(e)(1)
  • An FDA review must determine the device isn’t threatening to the public
  • The device must meet the approval of the importing country 

A simple notification should be given to the FDA when exporting a medical device that falls under Section 802. The main difference between an Export Permit Letter and simple notification is the issuer.  

Export Permit Letters are given by FDA and have to be earned by the exporter. Simple notifications don’t need prior approval by the FDA and can come straight from  the exporter. 

The notification should still have the following information:

  • Device trade name
  • Type of medical device
  • Model number
  • Name of the country the device will be exported if it’s a non-Tier 1 notification

If the exported shipment is to a Tier 1 nation, exporters can list the name or simply state the cargo is going to a Tier 1 country. 

To learn about the more generic paperwork required for shipping goods to other countries, read our article on the documents required for export. 

Cargo Export USA Provides Compliance Experts For Exporting Medical Devices from the U.S.

At Cargo Export USA, we’re ready to help you through these difficult guidelines. We offer a variety of services that will make sending goods to another country a much easier process. 

Some of the services we provide include:

  • Product Classification: Accurate categorization for streamlined export processes.
  • Export Licensing: Navigating regulatory hurdles for swift approvals.
  • Consulting: Speak with an experienced export professional to get help tailored to your unique circumstances.

When Cargo Export USA is in your corner, shipping goods to buyers in foreign countries will always end in success. Connect with us through our site today, or get into contact with our team at (866) 301-0635 if you have questions about the services we can offer. 

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