CE is the European market entry requirement, FDA is a US radiation-safety reporting obligation rather than an approval, and a Chinese public-security test report is what domestic tenders ask for. Most exporters need CE plus RoHS as a baseline, add FDA reporting if shipping to the US, and add the domestic test report only for tenders inside China.
| Mark | Market | What it means | Who issues it |
|---|---|---|---|
| CE | EU / EEA | Declaration that the product meets applicable directives (EMC, LVD, RoHS, Machinery) | Manufacturer self-declaration, with a test report from a lab |
| FDA | United States | Compliance with the performance standard for cabinet X-ray systems, plus product reporting | Manufacturer reports to FDA; FDA does not "approve" the product |
| 公安部检测报告 | China | Type test by a recognised security-equipment testing centre | Testing centre, report used in domestic tenders |
A baggage scanner typically falls under EMC (2014/30/EU), Low Voltage (2014/35/EU) where mains voltages apply, RoHS (2011/65/EU) and the Machinery Directive. Compliance is demonstrated through a technical file, a risk assessment and test reports; the manufacturer signs the declaration of conformity. There is no central register and no certificate to display — the declaration plus the technical file is the evidence.
Cabinet X-ray systems sold in the US must comply with the performance standard in 21 CFR 1020.40 (leakage radiation, interlocks, warning labels) and the manufacturer must submit a product report before introduction. Buyers sometimes ask for an "FDA certificate" — what exists is an accession number confirming the report was filed. Anyone offering to sell you an FDA approval certificate for a security scanner is selling you a document that does not exist.
Domestic procurement documents usually require a type-test report from a recognised security-equipment testing centre, sometimes with a specific validity window. This is separate from CE: a CE-marked machine without the domestic report can still be disqualified from a Chinese tender.
Assuming CE covers everything. It does not cover US reporting, and it does not replace a domestic type test.
Using a supplier's CE certificate. The declaration must be issued by the entity placing the product on the market; a component supplier's certificate does not transfer.
Forgetting the technical file. A CE mark without the underlying test reports and risk assessment will not survive a customs or tender review.
Treating the report as permanent. Standards are revised; a report against a withdrawn standard may be rejected even if it is still within its nominal validity.
How long does CE take? With an existing test report and technical file, days. Without, budget two to four weeks for testing plus document preparation.
Can one report cover both CE and FDA? The radiation measurements are largely shared, but the paperwork and the legal obligations are separate.
Does CE cover the UK? No — the UK uses UKCA, though CE is still accepted in many cases; check the current rules before shipping.
Tell us the destination market and the model, and we will list the documents that machine needs: 5030C, 6550C, 8065C.
