Certificate of Free Sale for Medical Devices
The American World Trade Chamber of Commerce (AWTCC) issues Certificates of Free Sale to support U.S. medical device businesses with international documentation. Foreign buyers, distributors, and regulatory authorities often demand evidence of a product's U.S. commercial status during import, registration, or market entry.
Need export documentation for your medical devices?
Why Medical Device Exporters Need a Certificate of Free Sale
You often encounter certificate requirements when you expand into foreign markets. Importers or overseas authorities frequently request documentation proving you sell or distribute a device in the United States before they finalize a registration, distribution agreement, or other regulatory process.
A Certificate of Free Sale for medical devices supports these documentation needs, but you must first determine exactly which certificate and issuing authority the destination market accepts.
Certificate of Free Sale vs. Certificate to Foreign Government
Medical device exporters must understand this distinction before applying. The FDA issues a Certificate to Foreign Government (CFG) for medical devices you legally market in the United States that meet applicable requirements. The FDA's Center for Devices and Radiological Health (CDRH) issues these medical-device export certificates.
AWTCC provides a completely separate, Chamber-issued Certificate of Free Sale for eligible U.S. businesses and products. A Chamber-issued certificate and an FDA-issued CFG serve different documentation purposes. Never automatically replace one with the other.
Before you start your request, confirm whether the overseas authority requires:
A Chamber-issued Certificate of Free Sale
An FDA Certificate to Foreign Government
Another FDA medical device export certificate
A document from a different issuing authority
Verifying this detail prevents delays caused by submitting the wrong type of certificate.
What Is an FDA Certificate to Foreign Government for Medical Devices?
The FDA Certificate to Foreign Government documents the regulatory or marketing status of qualifying medical devices in the United States.
According to the FDA, establishments may request a CFG for devices they legally market in the U.S. The FDA considers factors such as establishment registration, device listing, applicable premarket authorization or exemption, labeling requirements, and manufacturing requirements.
The FDA also issues other types of medical-device export certificates depending on the device's U.S. marketing status. If your customer asks for an "FDA Certificate of Free Sale" for medical devices, force them to clarify whether they actually require a Certificate to a Foreign Government.
Information You Need for a Chamber-Issued CFS
Your specific company, device, and destination requirements dictate the documents and information you need.
You typically must prepare:
Company and exporter information
Medical device names
A complete list of products for the certificate
Information proving U.S. commercial sale or distribution
Relevant supporting documents (when requested)
AWTCC carefully reviews all submitted documentation through our secure Chamber certification workflow.
How AWTCC Supports Medical Device Exporters
AWTCC helps U.S. companies manage Chamber-issued export documentation through a secure, traceable process.
Our Certificate of Free Sale service helps businesses:
Submit documentation electronically
Organize product and company information.
Prepare documentation that overseas business partners request
Eliminate avoidable paperwork errors.
Coordinate related export-document requirements.
AWTCC also supports U.S. exporters and freight forwarders who manage medical-device export documentation.
From Application to Chamber-Issued Certificate
1. Prepare Your Request
Gather your company information, device details, and applicable supporting documentation.
2. Submit the Documentation
Send the required materials through AWTCC's Certificate of Free Sale portal for Chamber review.
3. Use the Certificate for Your International Requirement
After AWTCC reviews your application and issues the certificate, deliver it to your importer or destination authority as instructed.
Foreign requirements change frequently, so verify current documentation rules before you apply.
Does Your Certificate Require Further Authentication?
Some overseas authorities demand additional authentication after AWTCC issues a document.
Depending on the country and document type, you may need an apostille, authentication, or consular legalization. AWTCC provides comprehensive apostille and document legalization services, along with a document legalization-by-country resource for businesses managing international documents.
Other Certificate of Free Sale Services
If your business exports products across multiple industries, AWTCC also provides Chamber-issued Certificate of Free Sale documentation for other product categories.
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Certificate of Free Sale for Cosmetics & Personal Care Products
Support documentation for U.S. cosmetics and personal care products entering international markets.
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Certificate of Free Sale for Dietary Supplements
Certificate support for U.S. supplement businesses responding to overseas registration, importer, or distributor requirements.
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Certificate of Free Sale for Food & Beverage Products
Chamber-issued documentation for food and beverage companies managing international market-entry requirements.
Request a Certificate of Free Sale for Medical Devices
AWTCC helps U.S. medical device companies prepare Chamber-issued Certificates of Free Sale for complex international documentation needs.
Does your overseas customer need a Chamber-issued CFS or an FDA certificate for a foreign government? Confirm the requested issuing authority before you submit your documentation.
For additional export-document support, contact AWTCC.
Frequently Asked Questions
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A Certificate to Foreign Government is an FDA export certificate for medical devices you legally market in the United States that satisfy applicable FDA requirements. The FDA's Center for Devices and Radiological Health issues the certificate.
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No. The FDA issues the Certificate to Foreign Government, while AWTCC provides Chamber-issued Certificates of Free Sale. Confirm which certificate the destination authority requires.
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For medical devices, the FDA's current export-certificate terminology uses "Certificate to Foreign Government" rather than formally titling it “Certificate of Free Sale.” Older FDA materials note that they formerly referred to these certifications as Certificates for Products for Export or Certificates of Free Sale.
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The device's regulatory status and the importing country's requirements determine the correct certificate. The FDA offers several medical-device export certificate types, while other organizations provide different supporting documents. Confirm the requested certificate with the foreign authority or importer before you apply.
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No. The importing country's authorities independently determine product registration, import, and documentation requirements. A certificate does not guarantee customs clearance or regulatory approval.