WHAT TO CONSIDER TO ENSURE THE QUALITY OF YOUR MOUTH AND NOSE PROTECTORS
Although there has been much discussion on the matter, the situation remains the same and there is a very variable quality and significant outright counterfeiting of products on the market. In particular, we see a lot of packaging that does not have the correct packaging labels. Since products in China are always checked at customs, the products in question are almost certainly either repackaged or smuggled if they do not have the correct labels or there are stickers on the packaging. Everyone can assess for themselves what risks there are in terms of quality in this case.
We have compiled here all the things that need to be taken into account in this matter. So-called folk masks are outside of these. For them, control is only carried out mainly in the country of dispatch and partly by customs upon import. However, the same applies to them, i.e. the products must not have labels and the factory name must be printed on the packaging and the product labels must be correct.
THE PRODUCT COMPLIES WITH DIRECTIVE 93/42/EEC (DIRECTORY 2017/745 FROM 05/2021)
CE marked face masks should comply with the provisions of Directive 93/42/EEC. In practice, public healthcare buyers are well aware of the required documents, but in the consumer market, the packaging has CE markings with manufacturer's declarations, etc. Usually, the packaging then lacks the marking from the EN14683:2019 standard and, for example, only the BFE number is marked. This is in principle quite possible, but, for example, the importer's declaration is naturally not the same as that of a reliable testing institute. In more demanding professional use, the conformity of the directive must always be confirmed by a third party, which in the case of face masks is TUV.
THE PRODUCT HAS RELIABLE TEST RESULTS
There has been progress in this regard and a large number of products have quite valid test results. In China, this is also regulated, meaning that their CNAS-approved test facilities are the highest quality. However, the best institutions for testing the EN14683:2019 standard are the most reputable ones operating in Western countries, such as SGS, TUV and Nelson. The BFE number is important, but the product is also required to have test results for hygiene (Microbiological cleanness) and permeability (which significantly affects the comfort of the product in use). The test results always apply to sample pieces and therefore it is important that the factory is reliable, experienced and also meets other requirements.
CE MARKING (DECLARATION OF CONFORMITY)
We have seen a large number of CE certificates issued by the importer. The highest quality suppliers have a company separately approved in the EU that provides confirmation. In Finland, hospital-grade protective equipment is supervised by FIMEA, professional protective equipment by AVI, and public masks by Tukes. The EU's official third-party CE marking is always issued by TUV. FIMEA can grant an exemption during COVID for products that do not have an official third-party CE certificate. In this case, FIMEA monitors that the product has reliable documents. In practice, for hospital use, the product should therefore have either a TUV certificate or an official FIMEA exemption.
PRODUCTION COMPLIES WITH CERTIFICATE (ISO13485 CERTIFICATE FOR MEDICAL)
In order for the production to also correspond to the prototype, it is worth choosing a manufacturer whose production process is ISO certified. The certificate for the manufacture of medical devices is ISO 13485. If the factory is new, it is difficult to ensure quality. Since obtaining materials is still difficult, without a functioning network, production process and quality control, it is quite certain that production does not correspond to the classifications of all suppliers. Regarding the requirements set for the material, it is said that it has been difficult for protective equipment manufactured in Finland to meet the Type II or Type IIR requirement.
SUPERVISION IN THE COUNTRY OF SENDING
The export of Covid products is also closely monitored in the sending country (almost always China). Manufacturers of protective equipment exported for medical use are designated in China (so-called whitelist) and legally exported products meet the following criteria:
-All markings are printed on the packaging, stickers, etc. are not accepted.
-The factory name and product batch number are marked on the packaging. The expiration date AND product name are also displayed.
-If the product has a CE marking, the product type (Type I, Type II and Type IIR) and EN14683:2019 must also be printed on the box
-Inside the package is a QC card confirming factory information and product properties, including compliance with EN14685:2019.
IMPORTER AND SELLER
It is also worth making sure that the supplier has reliable references and also the Vastuu-Group's reliable partner mark. This way you can ensure that taxes and other obligations have been taken care of. Naturally, it is also worth favoring domestic companies, in which case all taxes remain in Finland. It is also a good idea for the seller to carry out their own quality control. We have our own office in China, which regularly visits the factory and ensures that the factory complies with requirements such as quality, working hours legislation, working conditions, etc.
Leave a comment (all fields required)
Comments will be approved before showing up.
