With the worldwide spread of COVID-19 coronavirus pneumonia, more and more countries and regions need a large number of anti-epidemic medical supplies urgently. As China's epidemic situation stabilizes, many Chinese manufacturers begins to export masks. But what regulations does Chinese customs have on mask exporting? What are the requirements of foreign customs for mask importing?
Prerequisites for export declaration
- Registration code for consignee or consignor of imported or exported goods (charitable organizations may use temporary codes)
- Paperless customs clearance legal entity card is a must
For manufacturer, sales units and domestic consignors, apart from domestic production and market circulation qualifications, China Customs has no special requirements for mask exporting.
Requirements for export declaration
1. Commodity classification: Except for special cases, most masks should be classified under HS Code: 63079000.
2. Mask doesn’t belong to statutory inspected product. Quarantine field doesn’t need to be filled out by customs declaration. According to the agreements between Chinese and foreign governments, only before being exported to few countries, such as Iran, the masks should be quarantined before loaded.
3. Tariff exemption: If the mask is exported as general trade, Levy or exemption should be general tax, taxes should be levied in compliance with statutory tariff；If the mask is a donation, the inland consignor is trade agent or charitable organization[0.5秒]the levy or exemption field could be left blank, all taxes could be fully exempted.
4. Prohibition and restriction management of mask export
Currently, the Ministry of Commerce doesn’t set any requirements of trade control, the Chinese customs also doesn’t have any requirements of Port inspection of regulatory documents for protective materials.
5. Specification of Mask Export Declaration
The declaration of mask export should fill in commodity name and ingredient content as requested by the standard declaration requirements. If the mask is not made in China, the country of origin is filled in according to the actual country of production.
6. Tax Refund of Mask Export
The tax refund rate of mask export is 13%
7. U.S. companies could apply to additional tariff exclude of mask import, but only a few companies are currently exempt. The list of companies could be checked on U.S. Trade Representative Office website: https://ustr.gov/
Qualifications and documents required for domestic export trading companies
1. Business license (business scope should cover relevant business content)
2. Production license (refer to the manufacturer of masks)
3. Product testing report (refers to the report provided by the mask manufacturer)
4. Medical device registration certificate (required for medical masks only, masks are secondary medical devices, so secondary medical device registration certificates are required)
5. Product manuals, labels, product quality and safety certificates or certificates (provided along with the product)
6. Product batch / number (printed on the packaging)
7. Product sample diagram and outer package diagram
8. The trading company must obtain the registration of the customs consignee and consignor (that is, it can provide the customs 10-digit code, the charity can be a temporary code, and it must apply for a paperless customs clearance corporate card)
Certification of domestic mask manufacturer
1. For manufacturer of ordinary masks for personal protection or industrial non-medical use, enterprises with import and export rights can export masks directly.
2. For masks belonging to the medical devices for export, the Chinese Customs do not need enterprises to provide relevant certifications, but generally the Customs of imported countries requires manufacturers to provide relevant certificates of products to prove that the imported goods have been legally listed in China. The required certificates are as follows: :
1. Business license (business scope should include medical equipment for medical-use masks).
2. Medical device product registration certificate
3. Manufacturer test report.
Production enterprises have the right to import and export can export by themselves. If they do not have the right to import and export, they can conduct the exporting through foreign trade agents.
Basic qualifications required for domestic trade enterprises to export
1. Obtain a business license from the market supervision department and increase the business scope of "import and export of goods, technology import and export, and agency import and export."
2. Obtain the import and export right from the commerce department, and apply directly on the unified platform of the business system of the Ministry of Commerce (http://iecms.mofcom.gov.cn/) and submit the materials online.
3. Apply to the State Administration of Foreign Exchange for permission to open a foreign exchange account.
4. Go through customs registration for consignees and consignors of imported and exported goods.
Market access conditions
Required Documents：Bill of lading, packing list, invoice.
Personal protective mask：US NIOSH test certification, the National Institute for Occupational Safety and Health certification.
Medical masks：Must obtain US FDA registration.
Required Documents: Bill of lading, packing list, invoice.
Personal protective mask：The EU standard for personal protective masks is EN149. According to the standard, masks are divided into three categories: FFP1 / FFP2 and FFP3. All masks exported to the European Union must obtain CE certification. CE certification is a compulsory product safety certification system implemented by the European Union to protect the lives and property of people in EU countries.
Medical masks：The corresponding EU standard for medical masks is EN14683.
Products sold in the European Union need to issue the EU Free Sale Certificate. With the CE mark and the EU registration required by the relevant directives, Chinese manufacturers do not need a free sales certificate to export to the EU.
Required Documents: Bill of lading, packing list, invoice, manufacturers outside Japan must register manufacturer information with PMDA.
Mask packaging requirements
The package is printed with 99% of ウ ィ ル ス カ ッ ト (Chinese translation: virus blocking)
PFE: 0.1um particulate filter efficiency
BFE: bacterial filtration rate
VFE: Virus Filtering Rate
Mask quality standards
1. Medical protective masks: in accordance with China's GB 19083-2010 mandatory standard, filtration efficiency ≥95% (tested with non-oily particles)
2. N95 mask: American NIOSH certification, non-oily particulate matter filtration efficiency ≥95%.
3. KN95 mask: meets China's GB 2626 compulsory standard, non-oily particulate matter filtration efficiency ≥95%.
Required Documents: Bill of lading, packing list, invoice, Korean importer business license.
Personal protective mask standard
KF (Korean filter) series is divided into KF80, KF94, KF99
Implementation of standard specifications
MFDS Notice No. 2015-69
The regulatory thresholds for the admission of Korean medical devices are basically classified into categories I, II, III, and IV, and the license holders are Korean companies (License holders). Korean consignees must go to the Korea Pharmaceutical Traders Association Korea Pharmaceutical Traders Association. Advance import filing qualification (No, it doesn't work) Website: www.kpta.or.kr.
Required Documents: Bill of lading, packing list, invoice.
Must be registered by the Australian TGA and comply with the standard specification: AS / NZS 1716: 2012, which is the standard for respiratory protection in Australia and New Zealand.
TGA is the abbreviation of Therapeutic Goods Administration, which stands for Therapeutic Goods Administration. It is the Australian regulatory body for therapeutic goods, including medicines, medical devices, genetic technology and blood products. Australian medical devices are classified into Class I, Is and Im, IIa, IIb, III. The product classification is almost the same as the EU classification. If the product has obtained the CE mark, the product category can be classified according to CE.
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