More than 90% of CE certificates are fake! Just now, the EU officially issued a warning...

More than 90% of CE certificates are fake! Just now, the EU officially issued a warning...

Recently, the European Safety Federation (ESF), the EU's food and drug safety agency, issued an official warning: Regarding the "certificates" used as the basis for the CE marking of PPE (including FFP2/FFP3 masks and goggles), these "certifications" are forged or issued without authorization. These "certificates" have no legal value and cannot be used as conclusions for conformity assessment!


In this EU ESF official warning, ESF pointed out that these so-called "certificates" used as the basis for the CE marking of PPE (including FFP2/FFP3 masks and goggles) have the following serious problems:

1. These so-called "certifications" have no legal value!

2. These "certifications" cannot be used as valid proof of product qualification

3. It is not clear whether these documents are actually issued by some (unauthorized) organization themselves, or whether they are completely forged!

At the same time, the European Safety Federation (ESF) pointed out in the announcement that for any product imported into the EU from outside the EU, a Declaration of Conformity (DoC) must be provided and checked.


In addition, ESF also named 21 non-compliant companies, including 9 from Europe and 10 from China .


The nine European certification bodies named are: ICR Polska, CELAB, ISET, ECM, NPS, Amtre Veritas , STS Inspection and Certification, VIC Testing and Certification, and BSI.


The 10 Chinese certification bodies named are:




CIC (Shenzhen CIC Testing Technology)

Huaxun (Shenzhen HX Detect Certification)

ENC (East Notice Certification Service)

HTT (Shenzhen HTT Technology)

ITC (Shenzhen ITC Product Testing)

BTK (Guangzhou Bestek Testing Services)

Micez (Shanghai MICEZ Testing & Technical)

Huawei (Shenzhen Huawei Testing Certification)

LTT (Shengzhen LTT Testing Technology)

AST.LAB (Aerospace Testing Technology (Shenzhen)






How to distinguish the authenticity of mask certification?


0 1

China


Medical masks are classified as Class II medical devices in China and are registered and managed by provincial-level drug regulatory authorities. They can be queried through the medical device access number query.


First open the official website

http://www.nmpa.gov.cn/


Select data query under the "Government Affairs Disclosure" column

http://www.nmpa.gov.cn/



After entering, select the medical device column as needed.

http://www.nmpa.gov.cn/



After entering this page, you can search by entering the product information indicated on the smallest independent packaging of the product according to the above instructions.



0 2

USA


Medical masks are classified as medical devices in the United States and are managed by the U.S. Food and Drug Administration (FDA). Recently, the FDA personally refuted the rumor and stated on its official website that it would not issue certification certificates to any company.



The mask products that have been approved by the US FDA can be queried through their official website to check the registration certificate number.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm



According to the latest FDA policy, masks that meet Chinese standards are currently recognized if certain conditions are met.

The authorized company link is https://www.fda.gov/media/136663/download




0 3

European Union


There are many kinds of CE certification certificates on the market, and some are almost indistinguishable from the real ones. Companies applying for certification can ask the issuing agency two questions:

0 1

Is your company a NB institution? Can the institution number be checked?

0 2

Can the issued CE certificate be checked on the official website?



(Common fake CE certification certificates, pictures from the Internet)


The EU has announced a series of institutions that are authorized by the EU for unified supervision and certification qualifications, which we call NB institutions, and awarded each institution a unique four-digit code, namely the announcement number. The application and issuance of CE certificates are issued by the announcement number institutions authorized by the corresponding regulations and directives.


Links below

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main



Corresponding to the NB authorization number obtained, click on the corresponding code location, and then you can query the instructions authorized by the agency. The certification certificate issued for instructions within the scope of authorization is valid. At present, the EU and mask-related directives are: Medical Device Directive 93/42/EEC (MMD), New Medical Device Regulation (EU) 2017/745 (MDR), Personal Protective Equipment (PPE) Regulation (EU) 2016/425.




04

South Korea


Medical surgical masks are classified as Class II medical devices in South Korea. MFDS (Ministry of Food and Drug Safety of South Korea) implements pre-market approval for Class II devices. South Korea stipulates that importers of such products should ensure that imported products meet the requirements of the quality management system and obtain permission from the MFDS authorized agency. MFDS only issues certificates to domestic companies, and the Korean representative has heavier responsibilities, so there is no need to worry too much about the authenticity of the certificate.



05

Australia


Mask products in Australia need to be registered with the Australian Government's Health Goods Administration (TGA). TGA is Australia's supervisory body for therapeutic goods (including drugs, medical devices, genetic technology and blood products). According to the Australian Therapeutic Goods (Medical Devices) Regulations 2002, Australia's classification of medical devices is almost the same as the EU classification. If you have obtained a CE certificate issued by the EU Notified Body, it can be recognized by TGA and can be used as an important registration document to meet Australian safety regulations. After TGA approval, an ATRG registration number will be generated, and the query method is as follows.


First, go to the official website

http://www.tga.gov.au/



Select 'Australian Register of Therapeutic Goods (ARTG)' in the box to start your search

http://www.tga.gov.au/


Source: Cross-border Live

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