For most medical equipment, these types of certifications are required. In the European Union, this is done through the CE certification process.
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After verifying dozens of potential Chinese manufacturing leads for medical supplies, I noticed that 3 certification companies tended to show up much more frequently than others. These are Ente Certificazione Macchine (Italy), ICR Polska (Poland), and Celab (Italy).
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I first noticed this when we started receiving Celab’s fake certificates for medical supplies, which made no sense to me because they are only accredited to complete “electromagnetic compatibility” certification https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=search.nb&refe_cd=NANDO%5FINPUT%5F124828 …
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We then received ICR Polska certificates from potential suppliers, which was confusing because they are accredited for certifying “protective systems intended for use in potentially explosive atmospheres” which sounds like masks but isn’t https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=search.nb&refe_cd=NANDO%5FINPUT%5F233263 …
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And eventually we got loads of fake certificates by Ente Certificazione Macchine, which was very disconcerting because they are even accredited to certify “medical devices” but that still does not cover “personal protective equipment” https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=search.nb&refe_cd=EPOS%5F50158 …
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Personal protective equipment, like masks, is required to be CE certified before it can be sold on the European market — as it should be! Faulty products can kill you. All of these products have to adhere to “Regulation (EU) 2016/425”https://ec.europa.eu/growth/sectors/mechanical-engineering/personal-protective-equipment_en …
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The Nando database helpful lists which EU-based certification organizations are accredited for certifying products under “Regulation (EU) 2016/425” and you will see that ECM, ICR and Celab are not on it. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501 …
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And then a couple of days ago, ICR Polska all of the sudden put a warning message on top of all their webpages saying that “assessments carried out so far are of a voluntary nature” and “these certificates do not confirm conformity.” It seems like something spooked them.pic.twitter.com/0ulQt5YDVG
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So I started digging into what ICR meant by “voluntary nature” and I can tell you now: It’s not pretty.
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Turns out these companies have two business lines:
Actual regulatory certification
Fake certificates as marketing documents
Both of those look official, come with the same branding, and pass the document validation check.
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These certification organizations will sell fake certificates as “voluntary certification” which only has to live up to the certifier’s standards, not the regulatory ones. Manufactures can essential buy the branding of a legitimate certification organization for marketing.
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ECM calls this their “Voluntary Mark for Product Certification” and helpfully describes it as: “The Mark may only be used for advertising and promotional purposes and can not in any way refer to the product's compliance with regulations.” http://www.entecerma-it.cn/img/pdf/ECM-Mark-Regulation.pdf …pic.twitter.com/2xISQmdAox
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Celab is even more straightforward and says “the voluntary certificate is not for customs purposes or to demonstrate to the supervisory compliance with the requirements of the CE marking of a product.” https://celab.com/en/ce-marking/voluntary-certificate/ …pic.twitter.com/CFqeUfxU4X
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However, the real and the fake certificates both look official, come with the same logos, and show up in the same verification system. The only difference is that you have to carefully determine whether it’s a “voluntary one.”pic.twitter.com/JaC05xORrD
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I don’t know what the history is behind this, but it feels like a loophole. Some Chinese manufacturers are clearly abusing it in their effort to dump poor quality medical products onto the European market for a quick buck.
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I’m surprised that the European Union allows their accredited certification organisations to run a side-business handing out fake certificates based on the brand value they built within the official system. It’s unconscionable. Let’s fix it
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In case you’re wondering “do these fake certificates work,” I present to you: Well-meaning citizens donated 40,000 masks to the city of Vienna, with what seems to be a fake certificate https://www.ots.at/presseaussendung/OTS_20200331_OTS0106/corona-chinesische-community-uebergab-mehr-als-39000-mundschutzmasken-fuer-wiener-einsatz-organisationen … CE 2703 = ICR Polska = Fake https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=search.nb&refe_cd=NANDO%5FINPUT%5F233263 …pic.twitter.com/vNKAej34rh
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And the European Safety Federation has also taken note of these fake certificates: “We have the impression that manufacturers outside the EU (and probably even ‘newcomers’ and importers in the EU) are not entirely familiar with the EU Legislation” https://www.eu-esf.org/covid-19/4513-covid-19-suspicious-certificates-for-ppe …pic.twitter.com/pUgAn2MT70
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The official response of ICR Polska seems to be that manufacturers are aware that these documents do not certify conformity with the regulation. However, that’s clearly not how manufacturers, resellers or buyers are currently interpreting it in practice. https://www.eu-esf.org/covid-19/4513-covid-19-suspicious-certificates-for-ppe …pic.twitter.com/EO3UfoZ4lE
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Also note how ICR Polska has toned down their warning messagepic.twitter.com/dmgYcSj6eV
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So which organisations can you trust for mask certification? 32 in Europe: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501&pro_id=155522 … 45 in China: https://www.cnas.org.cn/english/photonews/03/902316.shtml …
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Find a supplier
Get their certificate
Figure out who issued it
Use the certifier’s website to validate it
Verify the certifier in the Nando database
This process works, but it could be much better
Few have security features
Some don’t list the certifier’s legal entity
Each certifier’s website works differently
Link (and QR code) to the certifier’s copy of the certificate


8 hours / 30 minutes = 16
8 hours / 5 minutes = 96
Email certifier to double check → Bounced
Domain registered from China
Server configured in Chinese
And yes, I’ll be NAMING and SHAMING some of these companies because they are putting the health of people at risk in times of crisis 