If you’re sourcing medical devices or in vitro diagnostic (IVD) products and a supplier shows you an “FDA registration certificate,” there’s a fact worth establishing first: the FDA does not issue any form of registration certificate to medical device companies. This isn’t our interpretation — it’s stated directly on the FDA’s own site: “The FDA does NOT issue registration certificates.” This article covers how to actually verify supplier credentials with the FDA and China’s NMPA, plus a few traps that are easy to misjudge.
1. On the FDA side: there’s no “certificate” — only a database entry
This is where medical device buyers get misled most often. The FDA states it plainly: once a company completes Establishment Registration and Listing, it does not receive any official certificate. At most, a company can print a registration confirmation from the FDA’s own system. Any document claiming to be an “official FDA-issued certificate” is itself worth a question mark — not necessarily because the supplier is lying, but possibly because of a genuine misunderstanding of the concept. Either way, it means you should verify differently, rather than debating whether a piece of paper is authentic.
The actual verification method:
- Search the FDA’s official Establishment Registration and Listing database directly (free, public, updated weekly) — enter the company name, registration number, or product code to see whether the establishment is genuinely on record.
- Require the supplier to provide their FEI (FDA Establishment Identifier) for verification — this identifier is more reliable than a “certificate,” since it’s the actual identity marker the database uses.
- A critical distinction: a company being “registered” does not mean the FDA has approved or cleared that specific product. The FDA’s own site explicitly warns: registration and listing information “does not denote approval, clearance, or authorization” of the establishment or its devices. In other words, a company appearing in the FDA database only confirms it has completed the required listing — it doesn’t mean the product itself has passed FDA safety/effectiveness review. These are two separate things to verify, not one.
- Registration must be renewed annually (between October 1 and December 31); registrations not renewed are removed from the database. For fiscal year 2026, the medical device establishment registration fee is $11,423 (small businesses with $1 million or less in gross sales may qualify for a fee waiver).
2. On China’s NMPA side: a free official database exists, but watch for the “not found ≠ fake” trap
Verification method: China’s National Medical Products Administration maintains a dedicated device query portal on its official site (nmpa.gov.cn), searchable by registration/filing number, company name, or product name — a free, public, authoritative primary source.
A useful numbering pattern worth knowing: Class I filing numbers follow a fixed structure — for example, “国械备20191220号” decodes as: “国” (imported product), “2019” (filing year), “1220” (filing serial number); “赣洪械备20230208号” decodes as a domestic Class I product filed in Nanchang, Jiangxi Province in 2023. The number itself carries information you can use for a basic sanity check (does the year actually match what the supplier told you?).
An important trap worth understanding, to avoid misjudging a genuine product as fake: domestic Class I filings and domestic Class II registrations are reviewed by provincial-level regulators first, then reported up to the national NMPA in stages. Because of this reporting lag, a product that was recently approved might not yet appear on the national site — that doesn’t mean it’s fake, just not yet synced up. If you can’t find a listing nationally, check the relevant provincial regulator’s site before concluding it’s fraudulent.
3. An ongoing reminder: registration isn’t permanent — track it continuously
NMPA regularly publishes certificate cancellation notices and results of unannounced “flying inspections” — for example, a notice published July 1, 2026 cancelled 31 medical device registration certificates in one batch (including electronic stethoscopes). This means a registration certificate a supplier shows you today could genuinely be valid — but might be cancelled six months later. For any long-term supplier relationship, it’s worth re-verifying registration status periodically (say, every six months), rather than checking once at the start and never again.
4. A specific IVD verification point: reagent and instrument need to be checked separately
If you’re sourcing an in vitro diagnostic reagent that’s meant to be paired with a specific instrument platform, verify the registration/filing status of the reagent and the instrument separately — a registered reagent doesn’t mean its companion instrument has also completed registration or filing in China. This is a specific, easily overlooked verification point unique to IVD products.
The bottom line
Verifying a medical device or IVD supplier’s credentials starts with correcting a common misconception: the FDA doesn’t issue “certificates” — only database records exist, and “registered” doesn’t mean “the product was approved.” China’s NMPA has a free official database you can search directly, but watch for the reporting-lag trap where a genuinely new registration hasn’t yet appeared nationally, and know that registrations can be cancelled after the fact — worth periodically re-checking for any ongoing supplier relationship, not just verifying once.
Verification procedures reflect official FDA and NMPA guidance as of mid-2026. Database availability, fee amounts, and specific procedures may change — verify current requirements against official FDA (fda.gov) and NMPA (nmpa.gov.cn) sources before making sourcing decisions. General regulatory framework information, not clinical, medical, or legal advice.