Written and maintained by CASRAI Editorial Board
Last updated
General information only, not medical or legal advice. This guide is about checking who makes a medical product, not about how to use it.
To find a medical supply manufacturer you can rely on, identify the legal maker of the exact product, look that establishment up in FDA’s registration database, then confirm in FDA’s device databases that the specific device is cleared, approved or authorized. FDA states that a registration entry “does not denote approval, clearance, or authorization of that facility or its medical devices,” so the lookup is one check, not the whole answer. If you are comparing distributors rather than makers, start with how to find wholesale suppliers for medical and lab supplies; for products sold in the EU, see CE certificate verification for medical devices.
What you need
- The exact product (name, model or catalog number) and its intended use as the supplier states it.
- The manufacturer’s legal name and site address, not only a brand or a distributor’s name. A distributor, an OEM and a private-label seller can all appear on a quote for the same item.
- Access to three FDA tools: the Registration and Listing search, Devices@FDA, and (where relevant) the De Novo database and the Emergency Use Authorization page for medical devices.
Steps
- Name the maker. Ask the supplier for the legal name and address of the facility that manufactures the exact product, and whether the supplier is that manufacturer or resells it.
- Look up the establishment. Search FDA’s Registration and Listing database. FDA says the database holds establishment registration and listing information, is refreshed weekly (typically Mondays), and returns at most 100 establishments per search, so narrow a broad search by name or location. A match shows the facility is registered and lists devices; it is not a quality or authorization finding. See FDA-registered establishment.
- Check the device itself. Search Devices@FDA, which FDA describes as “a catalog of approved and cleared medical device information from the FDA,” by device or company name. Novel low- or moderate-risk devices may appear in the De Novo database, and devices authorized during a declared emergency are listed on FDA’s EUA page for medical devices.
- Match the records to the claim. The company name, the product and the clearance, approval or authorization identifier should line up with what the supplier told you. Differences in name or product are questions to put back to the supplier.
- Ask for documents that point to these records. Request the establishment’s registration details, the identifier of the clearance, approval or authorization for the exact device, and, for an overseas maker, the name of its designated U.S. agent (see the FDA U.S. agent guide). Check each against the FDA databases rather than relying on the copy you were sent.
- For overseas makers, confirm the import roles. Foreign manufacturers need establishment registration and device listing and must designate a U.S. agent. The initial importer, who furthers the marketing of the device without repackaging or relabeling it, has its own duties, including registration, Medical Device Reporting and reports of corrections and removals.
What can go wrong
A supplier sends an “FDA registration certificate”
FDA states it “does not issue any type of device registration certificates to medical device facilities.” Documents of this kind often look official and may carry the FDA logo, but they are not issued by FDA. Treat one as a prompt to run the database checks yourself.
“FDA registered” is read as “FDA approved”
Registration and listing do not mean FDA reviewed the facility or its devices. Clearance or approval is checked per device in Devices@FDA or the De Novo database.
An approval from another country is assumed to carry over
FDA states: “The FDA does not recognize regulatory authorizations from other countries.” A CE marking, for example, is not an FDA authorization.
The shipment is held at entry
Entries for FDA-regulated products filed with U.S. Customs and Border Protection are also submitted electronically to FDA for review, and FDA states that products that do not meet its requirements “may be detained upon entry.”
When to get professional help
If a product’s regulatory status is unclear, if you plan to import devices yourself or act as an initial importer, or if records and supplier claims do not match, speak to a regulatory affairs professional or counsel, and to a licensed customs broker for entry questions. Clinical questions about a product belong with a qualified clinician.
FAQ
How do I find a manufacturer for a medical product?
Start from the exact product, get the maker’s legal name and address, and verify the establishment and the device in FDA’s databases as set out in the steps above.
How do I find a manufacturer for my product if it is a new medical device?
FDA’s Devices@FDA and De Novo databases show what has already been cleared, approved or authorized, which tells you whether a comparable device is on the U.S. market. Which regulatory route a new device needs depends on the device, so take that question to a regulatory professional before choosing a maker.
Is sourcing medical supplies from China different?
The same FDA requirements apply to an overseas maker as set out above: registration, listing, a designated U.S. agent, and an entry that FDA reviews. FDA does not recognize other countries’ authorizations, so a foreign approval does not replace FDA clearance, approval or authorization.
Do I need a China sourcing agent for medical supplies?
FDA’s import guidance requires a foreign manufacturer to designate a U.S. agent, which is a regulatory role and not a purchasing intermediary. Whatever intermediary you use, run the same registration and device checks on the actual maker.
Can I rely on Alibaba or another marketplace listing for medical supplies?
A marketplace listing is a supplier’s claim, not a regulatory record. Verify the named maker and the specific device against FDA’s databases before ordering.
Sources
- U.S. FDA, Are There “FDA Registered” or “FDA Certified” Medical Devices? How Do I Know What Is FDA Approved?, checked 2026-11-01.
- U.S. FDA, Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S., checked 2026-11-01.
- U.S. FDA, Search Registration and Listing, checked 2026-11-01.
