For the exit of respirator, you need to provide these information ↓ (the following is attached with the specific data chart)
1: Business license
2: Enterprise production license
3: Product inspection report
4: Medical device registration certificate
5: Product manual and label.
6: Product batch / No
7: Product quality safety book
8: Product sample picture and outer package picture
Commodity code reference of epidemic materials
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1. Is it possible to export such epidemic materials as masks?Answer: the Ministry of Commerce has explained to the outside world that such epidemic materials as masks can be exported normally.
2. What qualifications do enterprises need to export epidemic materials?
Answer: ordinary masks and other non-medical equipment management epidemic materials, without regulatory conditions, can be directly exported by enterprises with import and export rights. Three certificates of products are required for epidemic materials such as masks involving certificates: A. business license (business scope includes medical devices related), B. product record certificate or registration certificate, C. manufacturer's test report, and then enterprises with import and export business rights can export. In addition, if the enterprise wants to give away or purchase in place of overseas affiliated companies, it needs to provide a description.
3. In our company, we want to export a batch of masks with license, but we don't have export qualification. Can we export them?
Answer: if it is the product of a factory with three certificates, it can be exported through a foreign trade agent. If there is no three certificates, it cannot be exported.4. What qualifications and certificates are required for the export of general masks and medical masks?Answer: common and medical use refers to use. The administration of FDA is based on product quality and standards. The masks of class II and class III medical devices can only be exported if they need a registration certificate or registration certificate. See the answer to the second question for the three evidences related to the evidence.5. Trading companies do not have the qualification of medical devices, can they export masks? Manufacturers can provide three certificates. Is there any problem with tax refund?Answer: Yes, the three certificates provided by the manufacturer are completely exportable. Of course, the business scope of foreign trade company should include labor protection articles and other contents. In this way, export tax rebates are safer.6. I think 200 masks can be sent to the United States by personal express?Answer: personal postal service is not prohibited for export at present. In general, FedEx, UPS, DHL, EMS, SF and other express companies can be considered. However, some people reported that DHL would require the sender to provide FDA certification in the United States, some DHL simply refused, and some partners were rejected by FedEx. You can try the post office first, or you can call each express company before mailing. However, at present, we have received the news that there is no FDA certificate for masks, and the US Customs will refuse to enter the country.7. We produce melt blown cloth. Do we need medical equipment certificate for the outlet of melt blown cloth?Answer: the melt blown cloth is not a medical device, so it does not need medical device certification. About whether it is a medical device, you can go to the official website of the State Food and Drug Administration for inquiry.8. How to check whether the mask is qualified?Log in to the official website of the State Drug Administration (www.nmpa. Gov.cn), and then click the column of "medical devices" - domestic devices. According to the instructions on the page, enter the registration number or enterprise name of the medical device of the mask, you can know the production information of the enterprise related to the product, the approval number information, and you can know whether it is qualified.
9. If the mask is to be exported to Iran, do you need to apply for any certification?
Answer: it is still complicated to export to Iran. You need to apply for COI certification in Iran. Chinese is the compliance verification, which is the relevant inspection required by Iran's import compulsory delivery. At present, Iran's N95 mask and ordinary three-layer mask, respirator, surgical suit, nucleic acid test kit, personal protective equipment, protective mask and protective clothing are in urgent need. To encourage imports, Iran's economic Online reported on February 26 that the import tariff on masks in the Iranian market had been reduced from 55% to 5%.Necessary information (qualification)Bill of lading, packing list, invoice, business license of Korean importer, and Korean consignee need to go to Korea pharmaceutical Traders Association of Korean drug administration to record import qualification in advance (no problem) website: www.kpta.or.kr.In the case of enterprise's own use and donation, it can import by itself without relevant qualification.The mask also needs to have a detailed origin identification. If it is made in China, it must have a label: made in China, The manufacturer's information, shelf life, and preparation of component content description, manufacturing process flow, these documents have not been completed, but also need the goods to be sent to the laboratory for fine supervision test after arriving in South Korea, and can enter the Korean market for sale and circulation after passing the test.Necessary information (qualification)Bill of lading, packing list, invoicePMDA registered medical device companies exporting to Japan must meet the requirements of pharmaceutical and medical device act (PMD act) of Japan in order to put their products into the Japanese market. Under the requirements of PMD act, toroku registration system requires foreign manufacturers to register information with PMDA manufacturers.99% of the words and samples printed on the package are medical masks that exceed 95% of the domestic filtration efficiency (N95 mask)!PFE: 0.1um particle filtration efficiencyBFE: fine bacteria filtration rateVFE：virus filtration rateウィルスカット：virus interception1. Medical protective mask: it complies with the compulsory standard of China GB 19083-2010, and the filtration efficiency is ≥ 95% (non oily particles are used for testing).2. N95 respirator: NIOSH certified, the filtration efficiency of non oil particles ≥ 95%.3. Kn95 respirator: in accordance with the mandatory standard of GB 2626, the filtration efficiency of non oil particles is ≥ 95%Necessary information (qualification)Bill of lading, packing list, invoiceIn the European Union, masks are PPE personal protective equipment, "substances and mixtures dangerous to health". From 2019, the new EU regulation PPE regulation (EU) 2016 / 425 is enforced. All masks exported to the EU must obtain CE certification under the requirements of the new regulation.CE certification is a compulsory product safety certification system implemented by EU, which aims to protect the life and property safety of EU people.Necessary information (qualification)Bill of lading, packing list, invoiceIf the masks imported from the United States need to be sold, they must obtain FDA certification before they can be sold in the local market of the United States. For self-use and gift masks, when exporting, you'd better ask the receiving side of the United States whether FDA certification is also required, or purchase masks that have passed the FDA certification for export.NIOSH (National Institute of occupational safety and health) classifies its certified particulate respirators into 9 categories according to HHS regulations. The specific certification is operated by npptl laboratory under NIOSH.In the United States, according to the minimum filtration efficiency of filter material, masks can be divided into three grades - N, R, P.Class n masks can only filter non oily particles, such as dust, acid mist, paint mist, microorganism, etc. The suspended particles in air pollution are mostly non oily.R mask is only suitable for filtering oil particles and non oil particles, but the limited use time for oil particles shall not exceed 8 hours.Class P masks can filter both non oil particles and oil particles. Oily particles such as oil smoke, oil mist, etc.According to the difference of filtration efficiency, there are 90,95100 differences, respectively, which refer to the minimum filtration efficiency of 90%, 95%, 99.97% under the test conditions specified in the standard.N95 is not a specific product name. As long as the product meets the N95 standard and passes the NIOSH review, it can be called "N95 mask".Necessary information (qualification)Bill of lading, packing list, invoiceAs / NZS 1716:2012 is a respiratory protection device standard in Australia and New Zealand. The manufacturing process and test of relevant products must comply with this specification.This standard specifies the procedures and materials that must be used in the manufacturing process of particle respirators, as well as the determined test and performance results to ensure their use safety.
Partial information required for exportCustoms declaration form of the people's Republic of China for export goods ↓Type II medical device business record certificate ↓Some information of medical maskMedical device production license ↓Medical instrument registration certificate ↓Certificate of high tech enterprise ↓Manual of medical surgical mask ↓Record certificate of urgently needed medical devices for prevention and control in Guangzhou ↓Partial information of non-medical maskSome pictures of inspection and test report ↓National industrial product production license ↓China Union of labor protection equipment (cuppe)Traceability certificate of labor protection articles ↓Environmental management system certification ↓quality management system certification ↓Occupational health and safety management system certificate ↓Safety sign certificate of special labor protection articles ↓Export manager integration: forewarning platform for freight forwarders and foreign trade enterprises, Keyuan otech and quanguantong export tax rebate.
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