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    Customs Authority Issued: Guage Export Customs Clearance Guidelines For Trade Measures Have Been Attached To The Entry Requirements Of Various Countries.

    2020/3/18 10:20:00 0

    MaskExportTrade Guide

    In order to fully implement the spirit of the important instructions of general secretary Xi Jinping on coordinating the prevention and control of new coronavirus pneumonia and economic and social development, we implemented the 10 measures of the General Administration of Customs to support the resumption of work and production of foreign trade enterprises. We will promote the resumption and production of foreign trade enterprises, effectively digest domestic surplus capacity and surplus materials, and promote steady growth of foreign trade. The main technical trade measures of foreign countries, such as control of export customs clearance and collection and masks, are as follows:


    Export clearance tips


    Precondition for declaration

    The registration code of the consignee and consignor (charitable institution can be temporarily encoded) requires a paperless customs clearance legal person card.


    Export qualification

    The export of masks to the production and marketing units and the domestic shippers, except for the domestic production and market circulation qualification requirements, has no special qualification requirements of the Chinese customs.


    Export declaration requirements

    1. classification of commodities: Except for special cases, most of the masks should be classified as tax code number 63079000.

    2. inspection and quarantine: The mask is an illegal product. When it is declared, there is no need to fill in the inspection and quarantine items. According to the Intergovernmental inspection agreement signed by our government and the relevant countries, we need to carry out pre shipment inspection for products in a few countries such as Iran.

    3. customs exemption: If the export goods are of the nature of trade, the nature of the exempted declaration shall be generally taxed, and the exempted way shall be declared and collected according to the regulations. If the nature of the donation is the nature of the donation, the domestic shipper shall be exempt from the nature of the exemption and exemption from the exemption form.

    4. prohibition Management: At present, the Ministry of Commerce has not set up trade control requirements for masks, nor has there been any port inspection requirements for Chinese customs.

    5. declaration criteria: Fill in the commodity name and ingredient content according to the requirements of the specification; if the material is not produced in China, the country of origin will fill in according to the actual production country.


    Export tax rebate

    The export tax rebate rate for masks is 13%.


    Sino US tariff exclusion

    American enterprises can apply for excluding the import tariffs of masks, but only a few companies are allowed to exempt. For details, see https://ustr.gov/, website of the US trade representative office.


    Quick clearance guarantee

    In case of system failure such as single window, material export declaration can be contacted with the on-site customs for emergency disposal or call the customs 12360 hotline for consultation.


    The following contents are based on the relevant knowledge at home and abroad.

    Government agencies, professional websites, news reports

    Collected and sorted for reference only. Specific contents

    The relevant administrative departments and foreign official institutions shall be required.


    Preparation before export


    Explicit masks classification


    Generally speaking, foreign countries are divided into two types of personal protective and medical respirators.


    Qualifications and materials required by domestic export trading enterprises

    1. business license (business scope has related business content).

    2. enterprise production license (production enterprise).

    3. product inspection report (production enterprise).

    4. medical device registration certificate (not medical).

    5. product brochures (followed by products), labels (supplied with products).

    6. product batch / number (outer package).

    7. product quality safety certificate or certificate (followed by product).

    8. product sample picture and package picture.

    9. trade companies must be registered with the customs consignee and consignee.


    Qualification certificate of domestic export mask manufacturers


    The production of personal protective or industrial non-medical device management masks, import and export rights of enterprises can export directly.


    The production of medical masks is used for export. China customs does not need to provide relevant certificates. However, the general import Congress requires manufacturers to provide three products to prove that the imported goods have been legally listed in China.


    1. business license (including medical devices and non medical items).


    2. registration certificate or registration certificate for medical device products.


    3. factory inspection report.


    Production enterprises have the right to import and export, and they can export their own products. If they do not have the right to import and export, they can export sales through foreign trade agents.


    The basic qualification for domestic trade enterprises to export


    1., obtain business license from the market supervision department and increase the scope of operation, "import and export of goods, technology import and export, import and export of agents".


    2. the right to import and export to the business department can be directly applied to the unified platform (http://iecms.mofcom.gov.cn/) of the business department of the Ministry of Commerce and submit materials online.


    3. apply to the foreign exchange administration for permission to open foreign exchange accounts.


    4. customs registration for consignees and consignors of import and export goods


    Access conditions for masks in various countries

    Product access conditions


    U.S.A


    Necessary information Bill of lading, bill of lading, invoice.


    Personal protective mask The United States must obtain the NIOSH test and certification, namely National Institute for Occupational Safety and Health, the national occupational safety and Health Institute of the United States.


    Medical mask The US FDA registration is required.


    European Union


    Necessary information Bill of lading, bill of lading, invoice.


    Personal protective mask The European Union standard of personal protective masks is EN149. According to the standard, the respirators are divided into three categories: FFP1/FFP2 and FFP3. All masks exported to the EU must obtain CE certification. CE certification is a mandatory product safety certification system implemented by the European Union, with the purpose of ensuring the safety of life and property of the people of the European Union.


    Medical mask The European standard for medical masks is EN14683.


    Products sold in the EU need to issue the EU free sales certificate Free Sale Certificate. With the CE logo and the EU registration required by the relevant directive, Chinese manufacturers do not need free sales certificates to export to the EU.


    Japan


    Necessary information Bills of lading, boxes, invoices, manufacturers in Japan must register with PMDA manufacturers.


    Mask packaging requirements


    The package is printed with a button. Virus interception 99% words


    PFE:0.1um particle size filtration efficiency

    BFE: bacterial filtration rate

    VFE: virus filtration rate


    Quality standard of respirator


    1. medical respirator: in line with China's GB 19083-2010 mandatory standard, filtration efficiency of more than 95% (using non oil particle test).


    2. N95 respirator: NIOSH certification in the United States, non oil particulate matter filtration efficiency of more than 95%.


    3. KN95 respirator: in line with China's GB 2626 mandatory standard, non oily particulate matter filtration efficiency of more than 95%.


    The Republic of Korea


    Necessary information Bill of lading, bill of lading, invoice, Korean importer's business license.


    Personal protective mask standard


    The KF (Korean filter) series is divided into KF80, KF94 and KF99.


    Implementation of Standard Specification

    MFDS Notice No. 2015-69


    Regulatory threshold for access to medical devices in Korea The basic classification is I, II, III and IV. The holder is the Korea Companies (License holder). The South Korean consignee needs to go to the South Korean drug administration Korea Pharmaceutical Traders Association. to record the import qualification in advance (no no) website: www.kpta.or.kr.


    Australia


    Necessary information Bill of lading, bill of lading, invoice.


    Must pass through Australia. TGA registration It meets the standard specification: AS/NZS 1716:2012, which is the standard of respiratory protection in Australia and New Zealand.


    TGA It is the abbreviation of Therapeutic Goods Administration, the full name is the treatment Commodity Management Bureau, it is Australia's treatment commodity (including drugs, medical devices, gene technology and blood products) supervision organization. Medical devices in Australia are classified into I, Is and Im, IIa, IIb and III categories. The classification of products is almost the same as that of the European Union. If the product has obtained CE marks, the product categories can be classified according to CE.


    Brief registration procedures for registration and certification in various countries


    NIOSH certification in the US


    In accordance with the NIOSH guidelines, enterprises need to send samples to NIOSH labs for testing, and submit technical data (including part of quality system information) to NIOSH document examination. Only the text examination and test are approved, NIOSH will issue approval. NIOSH divides its certified particulate respirator into 9 categories, and the specific test is operated by the NIOSH subordinate NPPTL (National Personal Protective Technology Laboratory) laboratory. The main test indexes included expiratory resistance test, expiratory valve leakage test, inspiratory resistance test and filtration efficiency test.


    FDA registration in the US


    EU CE registration


    PMDA registration in Japan


    1. preparation stage. Confirm product classification (I, II special control, II control, III, IV) and product JMDN coding, select MAH (Japanese holder);


    2. manufacturers register factories with PMDA;


    3. II class special control products apply to the authorized certification body PCB for QMS factory audits. Other II products and III IV products apply to QMS for PMDA audit and obtain QMS certificates.


    4. apply for Pre-Market Apporval certificate, II class special control is issued by PCB, other II products and III class IV products are controlled by MHLW (Ministry of labor and labour).


    5. paying the application fee;


    6. registration documents rectification, registration and approval;


    7. all categories of products require MAH to be imported to the RBHW (Regional Health Organization) for registration before they can be imported.


    Korea KFDA registration


    The Ministry of health and welfare (MinistryofHealthandWelfare, MHW), the Ministry of health, is mainly responsible for the management of food, medicine, cosmetics and medical devices, and is the most important health care department. In accordance with the law on medical devices, the Ministry of food and drug safety of the Ministry of health and welfare of Korea is responsible for the supervision of medical devices. The KFDA registration process is:


    1. confirm product classification (I, II, III, IV), select KLH (Korean holder);


    2. II products need to apply for KGMP certificates and accept on-site audits. II products are generally authorized third party auditors and obtain KGMP certificates.


    3. II products need to send samples to Korea MFDS authorized Laboratory for Korean standard test.


    4. submit technical documents (test report, KGMP certificate, etc.) from KLH to MFDS (Korea food and drug safety department) for registration and approval.


    5. paying the application fee;


    6. registration documents rectification, registration and approval;


    7. designated Korean agents and distributors, product sales


    TGA registration in Australia


    According to Australian Therapeutic Goods (Medical Devices) Regulations 2002, Australia classifications medical devices into I, Is and Im, IIa, Im, and category. The classification of products is almost the same as that of the European Union. If the product has already obtained the mark, the product category can be classified according to the classification. If you have obtained the CE certificate issued by the Notified Body, it can be recognized by TGA and can be used as an important registration information to meet the Australian safety regulations.



    Comparison of mask technology standards in different countries

    (for manufacturers reference)



    Technical standards for mask countries

    (for manufacturers reference)


    The customs will continue to play the role of technical trade measures, continue to focus on and collect technical trade measures such as protective clothing, disinfectants and other export materials, such as export access conditions and technical standards, and timely issue guidelines to foreign trade enterprises to help enterprises resume work and resume production and expand exports.


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