FDA Export Certificates for Medical Devices: CFS, CFG, COE Complete Guide
Comprehensive guide to FDA export certificates for medical devices — Certificate to Foreign Government (CFG), Certificate of Exportability (COE), CECATS application process, fees, eligibility criteria, common mistakes, and step-by-step instructions for global market access.
FDA Export Certificates: Your Gateway to Global Medical Device Markets
More than 50 countries — including China, Brazil, Saudi Arabia, South Korea, Japan, and Mexico — require an FDA export certificate as part of their medical device registration process. Without the right certificate, your device cannot legally enter these markets, regardless of its FDA status in the United States.
The FDA's Center for Devices and Radiological Health (CDRH) issues four types of export certificates for medical devices, each serving a different regulatory situation. The application process runs through the CDRH Export Certification Application and Tracking System (CECATS), and understanding which certificate you need — and how to get it — is essential for any manufacturer with global ambitions.
This guide covers every certificate type, eligibility requirements, the CECATS application process, fees, timelines, common reasons for denial, and practical strategies for managing export certificates across multiple markets.
Why Export Certificates Matter
The Global Market Access Problem
Many non-US regulatory authorities require proof that a medical device has been reviewed and authorized by a competent regulatory body before granting local marketing authorization. The FDA is widely regarded as one of the world's most rigorous regulatory authorities, and a certificate from the FDA carries significant weight.
An export certificate from the FDA certifies in writing that an exported device meets certain specified requirements under US law. It does not guarantee approval in the target country — local registration processes still apply — but it often streamlines those processes and can reduce the data burden.
When You Need an Export Certificate
| Situation | Certificate Needed |
|---|---|
| Device is legally marketed in the US and you are exporting to a country that requires proof | Certificate to Foreign Government (CFG) |
| Device is NOT legally marketed in the US but meets section 801(e)(1) criteria | Certificate of Exportability 801(e)(1) (COE 801) |
| Device is NOT legally marketed and is being exported to specific listed countries under section 802 | Certificate of Exportability 802 (COE 802) |
| Product is non-clinical research use only | Non-Clinical Research Use Only (NCR) Certificate |
Types of FDA Export Certificates for Medical Devices
Certificate to Foreign Government (CFG)
The CFG is the most commonly requested export certificate. It applies to medical devices that are legally marketed in the United States and are in compliance with the FD&C Act.
Eligibility requirements:
- The establishment is registered with the FDA
- The device is listed with the FDA
- The device may be legally marketed in the US (cleared via 510(k), approved via PMA, De Novo, HDE, PDP, or exempt)
- The device is not the subject of an open recall
- All facilities involved in the manufacturing process are in compliance with applicable FDA regulations
- The device is being exported from the US
Acceptable marketing statuses: 510(k), PMA, Exempt, Pre-amendment, HDE, PDP, or De Novo.
Any medical device that is legally marketed in the US may be exported anywhere in the world without prior FDA notification or approval. The CFG is not a license to export — it is a certification of US marketing status.
Certificate of Exportability under Section 801(e)(1) (COE 801)
The COE 801 applies to devices that may NOT be legally marketed in the US but can still be legally exported under section 801(e)(1) of the FD&C Act. This is relevant for manufacturers who produce devices specifically for export markets.
Eligibility requirements for Class I and II devices:
- The device is in accordance with the specifications of the foreign purchaser
- The device is not in conflict with the laws of the country to which it is intended for export
- The device is labeled on the outside of the shipping package that it is intended for export
- The device is not sold or distributed in the US
This pathway allows manufacturers to export devices that have not received US marketing authorization, provided they meet the section 801(e)(1) criteria. The applicant must sign an Exporter's Certification Statement confirming compliance with these requirements.
Certificate of Exportability under Section 802 (COE 802)
The COE 802 is for devices that cannot be legally marketed in the US but are being exported to countries listed under section 802 of the FD&C Act. This pathway provides broader export authority for certain destination countries and has different criteria than COE 801.
Non-Clinical Research Use Only (NCR) Certificate
The NCR certificate is for the export of non-clinical research use only products, materials, or components not intended for human use, which may be marketed in and legally exported from the US under the FD&C Act.
Comparison of Certificate Types
| Feature | CFG | COE 801(e)(1) | COE 802 | NCR |
|---|---|---|---|---|
| Device legally marketed in US | Yes | No | No | Varies |
| Establishment must be registered | Yes | Yes | Yes | Yes |
| Device must be listed | Yes | No | No | No |
| Open recall check | Yes | No | No | No |
| Manufacturing compliance required | Yes | Varies | Varies | Varies |
| Export from US required | Yes | Yes | Yes | Yes |
| Signed certification statement | Yes | Yes | Yes | Yes |
| Typical use case | Global market registration | Export-only products | Export to listed countries | Research materials |
The CECATS Application Process
System Overview
The CDRH Export Certification Application and Tracking System (CECATS) is the electronic portal for all export certificate requests and simple notifications. Paper applications are no longer accepted — upon receipt of a paper application, requestors are contacted to submit via CECATS.
CECATS contact: cdrhcecats@fda.hhs.gov or 301-796-7400 (option 3)
Step-by-Step CFG Application
Step 1: Confirm Eligibility
Before applying, verify that:
- Your establishment is currently registered with the FDA
- Your device is listed with current information
- No open recalls affect your device
- All manufacturing facilities are in compliance
Step 2: Access CECATS
Log into the CECATS system and select "Create a New Application" for a CFG.
Step 3: Enter Manufacturer Information (Section 2)
Provide the manufacturer's registration number or Owner Operator Number (OON). The system retrieves the establishment information from FDA records. Verify the information and add the facility.
Step 4: Enter Distributor Information (Section 3)
Enter the US establishment that exports the devices. This is the US-based distributor, not foreign distributors. Provide the registration number or OON and retrieve the establishment information.
Step 5: Enter Device Information
For each device included in the CFG application:
- Device name and description
- 510(k) clearance number, PMA number, De Novo number, or exemption status
- Product code
- Proprietary/brand name
- Labeling samples (in some cases)
Step 6: Sign the Exporter's Certification Statement
The applicant must sign a statement indicating compliance with the FD&C Act. False statements may be considered a violation of United States Code Title 18, Chapter 47, Section 1001.
Step 7: Submit and Track
Submit the application through CECATS. The system provides tracking and status updates. CDRH will review and either issue or deny the certificate.
Fees and Timeline
Fee Structure
The FDA charges a fee for export certificates issued within 20 working days of receipt of the request. The fee structure is:
| Fee Element | Amount |
|---|---|
| Original certificate (first) | $175 |
| Additional certificates (same request) | $85 each |
| Export permit letters | No fee |
| Simple notifications | No fee |
Fee calculation example: A certificate with 80 pages requires 4 original certificates (80 ÷ 25 = 3.2, rounded up to 4). Total: ($175 × 4 originals) + ($85 × 4 additional) = $1,040.
No fee is charged if the certificate is not issued within 20 working days. However, if the certificate is issued within the 20-day window, the fee applies regardless of how quickly it is processed.
Processing Timeline
| Certificate Type | Typical Timeline |
|---|---|
| Medical device CFG (straightforward) | 5–10 business days |
| Medical device CFG (complex, multiple facilities) | 10–15 business days |
| COE certificates | 5–10 business days |
| NCR certificates | 5–10 business days |
| Drug CPPs (for reference) | 4–8 weeks |
Certificate Validity
Export certificates are typically valid for 1–2 years depending on the type and must be renewed upon expiration. The expiration date is printed on the certificate.
Certificate Authentication: Apostille and FECV
FURLS Export Certificate Validator (FECV)
Effective January 2, 2024, all CDRH export documents are issued electronically as downloadable PDFs through CECATS. Foreign governments and other parties authenticate those electronic certificates using the FURLS Export Certificate Validator (FECV) — accessible by scanning the QR code on the certificate or entering the certificate number at the FECV URL. The older CDRH Export Certificate Validation (CECV) database, updated weekly, remains available to look up paper certificates issued before the January 2, 2024 transition.
Apostille Requirements
Electronic certificates can still be apostilled. For apostille requirements, refer to the Authentication Service Form DS-4191 from the US Department of State. The FDA does not notarize export certificates.
Countries that are party to the Hague Apostille Convention typically require an apostille for FDA certificates. Check the specific requirements of your target country.
Countries That Require FDA Export Certificates
The following countries are known to require or strongly prefer FDA export certificates (particularly CFG) as part of their device registration process:
| Region | Countries |
|---|---|
| Asia | China, Japan, South Korea, Taiwan, India, Thailand, Philippines, Sri Lanka |
| Middle East | Saudi Arabia, UAE, Qatar, Oman, Jordan, Iraq, Lebanon, Egypt |
| Latin America | Brazil, Argentina, Mexico, Colombia, Chile, Peru, Ecuador, Bolivia |
| Other | Australia, Israel |
This list is not exhaustive. Always confirm requirements with the target country's regulatory authority or your local distributor before applying.
Common Reasons for Denial and How to Avoid Them
Denial Reason 1: Open Recalls
If any device on the CFG application is the subject of an open recall, the certificate will be denied. Check the FDA recall database before applying and resolve any open recalls first.
Denial Reason 2: Manufacturing Compliance Issues
If manufacturing facilities are not in compliance with applicable FDA regulations (e.g., unresolved Form 483 observations, warning letters), the certificate may be denied. The applicant should submit a plan of correction that includes:
- Steps to prevent recurrence
- Corrective and preventive actions taken or planned
- Timeline for completion
- Submit to the FDA contact identified by the investigator with "Plan of Correction" in the subject line, including the establishment name and FEI number
A response is generally delivered within 90 days. If the plan is sufficient and a CFG application is currently under review, the certificate will be issued if no other grounds for denial exist.
Denial Reason 3: Incomplete or Inaccurate Information
Missing device information, incorrect registration numbers, or mismatched product codes will delay or prevent issuance. Verify all information against your FDA registration and listing records before submitting.
Denial Reason 4: Unregistered Establishment or Unlisted Device
The establishment must be actively registered and the device must be listed. Expired registrations or inactive listings will cause denial.
Appealing a Denial
The FDA Reauthorization Act of 2017 (FDARA), Section 704, amended Section 801(e)(4) of the FD&C Act to establish a process for requesting review of FDA's decision not to issue a CFG. The guidance "Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices" outlines:
- The grounds for denial
- The information included in the denial notification
- The process for responding with corrections
- The process for requesting formal review of the denial
CFG vs. Certificate of Free Sale (CFS)
The Certificate of Free Sale (CFS) is a related but distinct document. The CFS confirms that a device is freely sold in the US market. Some countries accept a CFS in lieu of or in addition to a CFG.
| Feature | CFG | CFS |
|---|---|---|
| Issuing authority | FDA (CDRH) | State agencies or FDA |
| Scope | Federal compliance | Commercial availability |
| Application system | CECATS | Varies by issuer |
| Fee | $175+ per certificate | Varies |
| Recognition | Widely accepted globally | Accepted in many markets |
Check with your target market's regulatory authority to determine which document they require.
Managing Export Certificates Across Multiple Markets
Batch Applications
If you are registering the same device in multiple countries, you can request multiple original certificates in a single CECATS application. Each country typically requires its own original certificate.
Maintaining Certificate Currency
- Track expiration dates for all certificates
- Begin renewal applications at least 60 days before expiration
- Ensure registration and listing remain current (annual renewal Oct 1 – Dec 31)
- Resolve any recalls or compliance issues promptly to avoid future denial
Working with US Agents and Distributors
Foreign manufacturers without a US presence should work with their US Agent or a regulatory consultant to submit CECATS applications. The US Agent can interact with the FDA on the manufacturer's behalf.
FAQ
What is the difference between a CFG and a COE?
A CFG is for devices that are legally marketed in the US. A COE (Certificate of Exportability) is for devices that are NOT legally marketed in the US but can be exported under specific FD&C Act provisions (section 801(e)(1) or section 802).
Can I export a device without an export certificate?
Yes. Any device legally marketed in the US may be exported without prior FDA notification or approval. The export certificate is required by the importing country, not by the FDA for the act of exporting.
How long does it take to get a CFG?
Typically 5–10 business days for straightforward medical device requests. Complex applications or those involving compliance issues may take longer. Allow additional time if apostille authentication is needed.
How much does a CFG cost?
The FDA charges $175 for the first original certificate and $85 for each additional certificate if issued within 20 working days. No fee is charged if not issued within 20 working days.
My device has an open recall. Can I still get a CFG?
No. Devices that are the subject of an open recall are not eligible for a CFG. The recall must be resolved (closed by the FDA) before the certificate can be issued.
Do I need a separate CFG for each country?
Typically yes. Most countries require their own original certificate. You can request multiple originals in a single CECATS application.
Is the CFG the same as FDA approval?
No. The CFG certifies that the device is legally marketed in the US and complies with the FD&C Act. It is not a separate approval or clearance.
Can a foreign manufacturer apply for a CFG directly?
Foreign manufacturers need a US-based entity (US Agent, distributor, or authorized representative) to interact with the FDA. The application is submitted through CECATS, and the US Agent can handle the process on the manufacturer's behalf.
What if my device is Class I and 510(k)-exempt?
Class I exempt devices are eligible for a CFG as long as the establishment is registered, the device is listed, and all other eligibility criteria are met. Exempt status is an acceptable marketing status.
How do I authenticate my certificate for the target country?
Use the FECV system for electronic verification. For countries requiring apostille, submit the certificate and DS-4191 form to the US Department of State. The FDA does not notarize certificates.
Where can I get help with CECATS?
Email cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3 for CECATS support.