This week, the overseas certification and registration of "masks, protective clothing and infrared thermometers" of the three anti epidemic King Kong products suddenly became a hot spot, and various kinds of advertisements came. Take CE in OMG for 2-3 days and FDA for 2-3 weeks. For the above-mentioned products, CE may be industrial products, household appliances, personal protective equipment (PPE). Previously, we didn't know much about the way of CE certification for non-medical purposes. Recently, in order to solve the problems for customers, we worked hard to study it. The more we studied, the more "confused".

The above are the typical "FDA certificate" and "CE personal protective equipment (PPE) Certificate" on the market at present. Why are you quoting? Because the authorities do not recognize these certificates, or they are not certificates. In order to deepen our understanding and make a point, let's talk about the listing requirements of the European Union today, and then the listing requirements of the United States tomorrow. Please pay attention.

The masks in the EU can be exported as medical or personal protective equipment (PPE), but we think that the certification of medical masks takes a long time and costs a lot, so the enterprises that have recently inquired about it are very direct and require CE certification of PPE. You see, they said it for 2-3 days. Let's look at the PPE regulations together. According to the EU PPE regulation 2016 / 425 / EC, PPE is divided into three categories, I, II and III. Class I is a declaration of self-compliance, and class II and class III shall be intervened by the notified body. So visually, the certificate that can be handled in 2-3 days is class I, and a friend sponsored a recent certificate to give a supplementary certificate. In the spirit of learning, I looked at the laws and regulations again. Generally speaking, class I PPE is applicable to the contact of clean articles with mechanical protection and weak mobility. OK, you can stop here. If we use this mask in the clean workshop, this class is suitable. But as we all know, now anti epidemic, this mask is bought to protect substances that are harmful to health. It fully conforms to the definition of PPE III (a) substances and mixtures which are hazardous to health. The way of PPE class III certification needs the intervention of the public announcement agency. If the public announcement agency issues certificates normally, it will not be determined in 2-3 days. How long? I asked a few, a few months.

PPE is not good. Let's go back to the mask for medical use. The easiest way is not to sterilize the medical mask, but 2-3 days, anyway, I can't make it. Although class I does not need the intervention of the announcement agency, it is just a self-compliance statement, but the self-compliance statement is based on a complete and authentic technical document. At present, the European Union has made great efforts in random inspection of medical devices on the market, and anti epidemic goods are the top priority. What is spot check? First of all, I'd like to look for European union representatives to read their technical documents. If there is a problem with the technical documents, the product will be recalled, and both eurogen and the manufacturer will be punished. Therefore, before assisting enterprises to register in the EU database, the current European generation will review the technical documents of enterprises. Only when the technical documents are complete and consistent with the products, the European generation will accept and carry out the next step of registration. So in 2-3 days, if you have perfect technical documents, it may be feasible. If you have never made CE technical documents of masks, the following is a reasonable schedule: the fastest performance test is 1 month, the biocompatibility test is 45 days (at the same time with the performance test), the preparation of the documents is 1 week, the review of the documents is 1-2 weeks, the EU database registration, the total time of 1.5-2 months is reasonable. If you already have an en standard test report approved by CNAs, we can assist in the preparation of technical documents, which can be shortened to 2-3 weeks as soon as possible.

Finally, the sterilized mask. Sterilized masks need to be issued by the announcement agency, and cannot simply make a declaration of self conformity. The key point is "announcement agency". At present, no agency can issue 93 / 42 / EEC, or MDD certificate, because the new MDR regulations will be implemented on May 26. Warmly welcome the MDD license issuing agencies to face, for the sake of customers, we are willing to ~ so the license issuing cycle of sterilized medical masks is 6 months, that's speed. My friends, if we are going to rush to rescue the EU people suffering from the epidemic, we can disperse. If you think about long-term development, you can start to prepare immediately.

To sum up, the fastest and legal way is to prepare the technical documents according to the CE requirements of non sterile medical masks for class I medical devices, and then the EU representative will register in the EU database.

In this advertisement, Haihe consulting undertakes the preparation and application of FDA 510 (k) document, CE technical document, CE announcement agency recommendation and EU representative recommendation of various masks, protective clothing and infrared thermometer. If you are willing to do industrial infrared temperature gun, we can also help.

During the extraordinary period, I hope you can polish your eyes and contribute to the global epidemic prevention!

Tomorrow, we will continue to talk about the marketing of masks in the United States. We will see each other!