Many manufacturers assume FDA export certificates are only available for products exported from the United States. That is not always the case. Certain foreign-manufactured medical devices, including some Software as a Medical Device (SaMD) products and digital medical technologies, may qualify for FDA export certificates even when they are manufactured, distributed, and used entirely outside the United States.
CFG Experts helps manufacturers identify certificate opportunities, evaluate eligibility, and manage FDA export certificate applications from assessment through submission.
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.
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.
Manufacturers usually contact CFG Experts because they need practical answers before submitting an FDA export certificate request.
Engagements can begin with a complimentary screening or a paid written assessment, depending on how much detail your team needs.
A high-level review of public FDA registration, listing, inspection, and certificate information to identify whether a certificate opportunity may exist.
A written review of product eligibility, manufacturing arrangements, inspection history, certificate options, and recommended next steps.
Preparation of the certificate application and supporting information needed for a complete submission package.
When authorized, we manage submission activity, coordinate FDA correspondence, and assist with clarification or correction requests.
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 team of former federal agency and military logistics professionals use proprietary algorithms and AI-enriched FDA data models to identify certificate opportunities that remain hidden without our 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.
Many manufacturers discover FDA export certificate opportunities they did not know were available. A formal assessment provides a detailed review of eligibility, certificate options, manufacturing considerations, and potential next steps.