Your existing FDA registrations may be worth more than you realize. CFG Experts helps medical device manufacturers outside the United States obtain FDA export certificates, including the little-known CFG-NE, and use the registrations they already hold to reach new markets with fewer delays from application to shipment.
Before your discovery call, we prepare your Export Certificate Profile: a two-page review of your FDA establishment registrations, device listings, and international footprint.
| US | CA | EU | UK | AU | JP | VN | KR | |
|---|---|---|---|---|---|---|---|---|
| Firm Footprint | ✓ | – | ✓ | – | ✓ | – | ✓ | H |
| Expansion Fit | ↗ | ↗ | ↗ |
Most consultants start by asking you to fill in a questionnaire. We start with the public record. Your profile is built from FDA registration and listing data and from medical device registers in the markets you already serve, so the discovery call is spent on strategy, not fact-finding.
Your registered establishments, listed devices, and product codes, reviewed against FDA export certificate requirements, including the CFG-NE for devices that never pass through the United States.
Your firm matched against device registers across twelve markets, including Canada, the EU, the UK, Australia, Japan, China, Brazil, Taiwan, Vietnam, and Korea.
The markets where your existing FDA status and international registrations give you the clearest path forward, and what it would take to get there.
Start with a complimentary call. Go further only if the opportunity is real.
Choose a time and tell us your company name and manufacturing country. That is all we need to begin.
We walk through your Export Certificate Profile together and discuss strategies for accessing new markets.
A written review of eligibility, manufacturing arrangements, inspection history, certificate options, and next steps.
When authorized, we prepare the application, manage submission, and coordinate FDA correspondence.
The Certificate to Foreign Government for Device Not Exported from the United States, often called the CFG-NE, is an FDA-issued certificate available in specific circumstances for devices manufactured outside the United States and shipped from one foreign country to another.
Eligibility is often misunderstood. A device does not always need to be physically exported from the United States to be considered for an FDA export certificate. In some circumstances, FDA's authority can extend to foreign-manufactured products connected to devices commercially available in the United States through registration, listing, and product-family relationships.
This can be especially important for manufacturers of SaMD and other digital medical technologies, because qualifying products may never pass through customs at all. The key question is not simply whether a product crossed a U.S. border. The key question is whether the product, manufacturer, and FDA records support the certificate request.
FDA export certificate applications can appear simple, but the eligibility analysis is often where problems arise.
Product family relationships, manufacturing site selection, registration status, device listings, inspection history, and certificate language can all affect the application strategy.
A preliminary review can identify whether a certificate opportunity may exist before a manufacturer invests time in a formal application.
Many manufacturers miss certificate opportunities because they apply familiar assumptions from traditional exports, customs entries, or U.S. distribution history.
We work with organizations that maintain, support, or rely on FDA registration and listing records but need FDA-issued documentation for foreign regulators, distributors, tenders, or market access activities.
Manufacturers with FDA-regulated product families and international certificate needs.
Software and digital medical technologies that may qualify even without physical customs movement.
Organizations with complex manufacturing, listing, brand owner, or distributor relationships.
Teams that need additional capacity or specialized export certificate support.
Commercial partners asked to obtain FDA documentation for a foreign registration or tender.
Manufacturers supporting documentation requests across several foreign markets.
CFG Experts focuses on FDA export certification programs for medical device manufacturers, including overlooked certificate pathways involving foreign-manufactured devices, SaMD, digital medical technologies, and complex product-family relationships.
Our regulatory and logistics professionals combine decades of medical device experience with proprietary, AI-enriched FDA data models to identify certificate and market opportunities that remain hidden without exacting analysis.
For manufacturers with recurring documentation needs, CFG Experts can function as an outsourced FDA export certificate resource for regulatory, quality, commercial, and distributor teams.
Book a complimentary 30-minute discovery call. We will review your current FDA establishment registrations and device listings and evaluate strategies for accessing new markets and getting products to customers faster.