Original censusPublic data, fully reproducible
China FDA records: 38.8% declare contract manufacturing.
1,928 of 4,973 China establishments (38.8%) declared contract manufacturing in the FDA export dated 10 August 2026. Match the establishment, owner-operator and seller before relying on a registration number. Registration is a filing; it does not prove inspection or approval.
FDA CENSUS / 01
FDA registration does not prove inspection or approval
Does an FDA establishment registration prove a Chinese factory was inspected or approved?
No. An entry in the FDA registration and listing database does not show that a facility was inspected or that its devices were approved or cleared. This study describes filings; it does not rate facilities or products.
41,745 August listing records resolve to 4,973 establishments
Why are FDA listing-record counts not the same as company counts?
The August export has 41,745 China listing records and 4,973 distinct establishments. One establishment can have many listings. The median is 4 and the maximum is 648. Establishment counts are not necessarily legal-company counts.
We used all China records in the openFDA bulk export dated 10 August 2026. The full export has 333,181 records across all countries. No sample was drawn from the China records.
Retested on 6 September 2026 against the export dated 4 September 2026, with the same filter and the same de-duplication key. 42,098 listing records now resolve to 5,012 establishments. The median establishment still carries 4 listings and the largest carries 651. The two exports differ by 353 listings and 39 establishments over 25 days. The median stayed at 4; roles, names and agent shares below still use the August export.
The archived API query counted 14,368 listing records carrying the export role. In the deduplicated export, 1,828 establishments carry that role; 170 carry it with no other role. These counts use different units and filters. The overall ratio of 41,745 records to 4,973 establishments is not an export-only conversion factor.
170 of 4,973 August establishments declare the export role alone
How many establishments were registered only for the export role?
In the August export, 170 establishments (3.4% of 4,973) carry the export role and no other role. A broader group of 1,828 carries the export role, including establishments with other roles.
An establishment declares one or more roles at registration, so these shares sum above 100%.
| Declared role | Establishments | Share |
|---|---|---|
| Manufacture Medical Device | 4,193 | 84.3% |
| Manufacture Medical Device for Another Party (contract manufacturer) | 1,928 | 38.8% |
| Export to the United States but perform no other operation | 1,828 | 36.8% |
| Repack or relabel | 317 | 6.4% |
| Develop specifications but do not manufacture at this facility | 189 | 3.8% |
| Foreign private label distributor | 136 | 2.7% |
Nearly four in ten declare that they make devices for another party. This role is not a warning sign by itself. Check who owns the brand, who makes the device and who ships it; the names need not match.
These are declared roles, not proof that a supplier is a trading company or runs a factory.
The same structural question from the Chinese side of the record: who is the exporter, and why business scope no longer answers it.
A shared US agent is not a supplier endorsement
Foreign device establishments must designate a US agent for FDA communications. All 4,973 establishments in this export have an agent recorded. That field alone does not show that every filing requirement was met.
Those 4,973 establishments name 1,466 distinct US agents. Some agents serve far more firms than others:
732 establishments (14.7%) name the largest agent by count.
331 (6.7%) name the second-largest agent.
134 name the third-largest agent.
The ten largest agents together cover 1,763 of the 4,973 establishments, 35.5%.
At the other end, 1,111 of the 1,466 agents (75.8%) serve exactly one establishment. The aggregate does not establish their relationship to each supplier.
For a buyer, an agent entry identifies a contact for FDA matters. It does not show that the agent inspected the supplier, endorses its products or will handle a purchase dispute.
561 of 4,973 August establishments have different name strings
Each filing names an establishment and its owner-operator. We compared the names without case, punctuation or common company suffixes. The dataset lists the rules. They remove some text variants; they do not prove identity.
561 of 4,973 establishments (11.3%) have different establishment and owner-operator name strings after those rules.
A name difference can reflect a group structure, a naming variant or another relationship. This comparison does not resolve ownership or prove that two names identify different legal entities. Match both names to the supplier and check the relationship before relying on the filing.
For a separate study of former Chinese company names, see the registration census.
What this study cannot show
Medical devices only. Nothing here generalises to furniture, electronics or anything else. It is one regulated category with an unusually good public record.
US-facing registrations only. A Chinese factory with no US device business does not appear at all, so this is not a picture of Chinese manufacturing.
Registration is not approval. It does not mean the facility was inspected, or that its products were cleared. Declared roles are self-declared.
A different name is not wrongdoing. We report the frequency of a structural pattern and deliberately do not interpret individual cases.
Two dated exports, limited comparison. Roles, names and agent shares use 10 August 2026. The 4 September export retest covers record counts, establishment counts, median and maximum listings only; it does not update those other findings.
We did not contact any establishment, and we published no personal names. Every figure comes from a public bulk file that requires no account.
The data, and reproducing it
The aggregated dataset behind the August findings: fda-china-device-registration-census-2026-08-12.json.
Archived copies, each with its own DOI, resolving independently of this site: Zenodo · Harvard Dataverse · figshare.
A citation with everything it needs:
Currawong, “What a China FDA registration tells you: 4,973 measured”, census of the openFDA device registration-listing bulk export of 10 August 2026, deduplicated to 4,973 establishments, released 12 August 2026.
https://currawongweb.com/verify/fda-registered-facilities-china/
BibTeX
@dataset{currawong_verify_china_fda_registration_study_2026,
author = {Bao L. Zhou},
title = {{Chinese medical-device establishments registered with the US FDA: roles, name continuity and US agent concentration}},
year = {2026},
publisher = {Zenodo},
doi = {10.5281/zenodo.21897194},
url = {https://doi.org/10.5281/zenodo.21897194}
}To reproduce it, download the two openFDA bulk partitions for device/registrationlisting, keep the records whose registration.iso_country_code is CN, deduplicate on registration_number, and recompute. Use the dated source exports to reproduce these snapshots; a current download may produce different counts. The September retest dataset records its narrower scope.
The web dataset uses ranks in place of US-agent names. Counts and shares are unchanged. The 12 August archive predates that change. Use it as source history; use the web dataset for this release. Published under CC BY 4.0.
We kept China records from dated openFDA bulk files. We grouped them by registration number, or FEI number if that was missing. The August aggregate reports roles, names and agents; the September retest covers counts and listings per establishment only. FDA explains that registration does not establish approval or clearance (source checked 8 September 2026). A page edit does not refresh the data.
Browse all measured studies and methods in the research index.
Read the business-scope wording
Not legal advice, and not a rating of any company named or unnamed. The FDA filing alone cannot verify Chinese company identity. A Chinese company-record check alone does not verify a US device listing. Each check needs its own source, date and scope.
How we checked
We grouped China records in dated openFDA bulk files by registration number, using FEI when missing. Each export has its own date and scope. Last date marked for the checks: 6 September 2026. Use the date shown with each finding. A page update does not mean all checks were run again.
Use the source links. Check the dates and limits stated for each finding.
Being pushed to pay a deposit right now? The checks that matter before money moves are free to read.
If you want these records pulled for your own supplier: check the scope of the “Just check who they are” selection in the report menu before ordering. It covers the listed Chinese company-record checks, not FDA product approval or a facility inspection. Packs from $26.55. Delivery follows the window on your order confirmation. First paid order: unhappy for any reason, tell us within 14 days of delivery and it is refunded in full.