Medical epidemic prevention supplies are under martial law! From April 1, the export of medical epidemic prevention supplies requires customs registration!

Medical epidemic prevention supplies are under martial law! From April 1, the export of medical epidemic prevention supplies requires customs registration!

Starting from April 1st! New regulations for exporting medical supplies. In order to meet the needs of domestic epidemic prevention and control, the Ministry of Commerce will work with relevant departments to establish a working mechanism to strictly control the quality of relevant medical supplies and crack down on counterfeit and shoddy products.


Announcement No. 5 of 2020 by the Ministry of Commerce, the General Administration of Customs and the National Medical Products Administration on orderly export of medical supplies:

The global epidemic is spreading rapidly. On the basis of doing a good job in domestic epidemic prevention and control, orderly export of medical supplies is an important measure to deepen international cooperation in epidemic prevention and control and jointly respond to the global public health crisis.


In response to the current quality disputes over China's exported epidemic prevention materials, the Ministry of Commerce stated that once quality problems arise in the export of medical supplies, China will conduct a serious investigation, investigate and deal with each case discovered, and punish the offenders in accordance with the law, with no leniency.


Starting from April 1, companies exporting novel coronavirus testing reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers must provide written or electronic declarations when declaring to customs that comply with the quality standards of the importing country (region).


We must strictly control the export quality, especially in the current situation, to ensure the quality of medical supplies for foreign aid and commercial exports. This is a matter of life and death, and it also affects the reputation of Chinese manufacturing and even the entire China.


So what preparations should be made in advance for the export of masks? The editor summarizes the guidelines for customs technical trade measures.




Export customs clearance tips





Prerequisites for customs clearance

Consignor and consignee registration code (charitable organizations can use temporary codes) and paperless customs clearance legal person card

Export qualification

For mask export, Chinese Customs has no special qualification requirements for production and sales units and domestic shippers, except for meeting the domestic production and market circulation qualification requirements.

Export declaration requirements

1. Product classification : Except for special circumstances, most masks should be classified under tax number 63079000.

2. Inspection and quarantine: Masks are illegal products, so there is no need to fill in the inspection and quarantine items when declaring. According to the intergovernmental inspection agreement signed between the Chinese government and relevant countries, products exported to a few countries such as Iran must be inspected before shipment in accordance with regulations.

3. Tariff exemption: If the exported materials are of a trading nature, the exemption nature declaration will indicate general taxation, and the exemption method declaration will indicate taxation according to regulations; if the materials are of a donation nature, and the domestic consignor is a trade agent, charity organization, etc., the exemption nature does not need to be filled in, and the exemption method declaration will indicate full exemption.

4. Prohibition and restriction management: Currently, the Ministry of Commerce has not set any trade control requirements for masks, and China Customs has no port verification requirements for regulatory certificates for protective materials.

5. Declaration specifications: Fill in the product name and ingredient content according to the declaration specifications; if the material is not produced in China, the country of origin should be filled in according to the actual country of production.

Export tax rebate

The export tax rebate rate for masks is 13%.

China-U.S. tariffs excluded

US companies can apply to be excluded from the additional tariffs on imported masks, but only a few companies have been granted exemptions so far. For more information, please visit the US Trade Representative's website at https://ustr.gov/.

Fast customs clearance guarantee

If the export declaration of materials encounters system failures such as single window failures, you can contact the on-site customs to take emergency measures, or call the customs 12360 hotline for consultation.






Preparation before export





1

Clarify the classification of masks

Foreign countries generally divide masks into two categories according to their uses: personal protection and medical. Domestic export trading companies must have a business license, enterprise production license, product inspection report, medical device registration certificate (not required for non-medical use), product manual, product batch/number, product quality and safety book or certificate, product sample photos and outer packaging photos, and trading companies must obtain customs consignee and consignor registration.

2
Qualification certificate for domestic export mask production enterprises
When producing masks that are managed as medical devices for export, the importing country will generally require the manufacturer to provide a business license, a medical device product filing certificate or registration certificate, and a manufacturer's test report.
3
Basic qualifications that domestic trade enterprises need to obtain for export
Obtain a business license from the market supervision department and add the business scope of "import and export of goods, import and export of technology, and import and export agency". Apply to the State Administration of Foreign Exchange for permission to open a foreign exchange account. Handle customs registration for the consignee and consignor of imported and exported goods.




Mask access conditions in various countries





USA

Necessary information: bill of lading, packing list, invoice.
Personal protective masks: must be certified by the U.S. NIOSH, which is the National Institute for Occupational Safety and Health.

Medical masks: must obtain US FDA registration approval.


European Union

Necessary information: bill of lading, packing list, invoice.
(1) Personal protective masks: The EU standard for personal protective masks is EN149, which divides masks into three categories: FFP1/FFP2 and FFP3. All masks exported to the EU must obtain a CE certification. CE certification is a mandatory product safety certification system implemented by the EU, which aims to protect the lives and property of people in EU countries.
(2) Medical masks: The EU standard corresponding to medical masks is EN14683.


Japan

Necessary information: bill of lading, packing list, invoice. Manufacturers outside of Japan must register their manufacturer information with PMDA.

(1) Medical protective masks: comply with China's mandatory standard GB 19083-2010, with a filtration efficiency of ≥ 95% (tested using non-oily particles).

(2) N95 mask: US NIOSH certified, non-oily particle filtration efficiency ≥ 95%.

(3) KN95 mask: complies with China's GB 2626 mandatory standard, with a non-oily particle filtration efficiency of ≥95%.


South Korea

Necessary information: bill of lading, packing list, invoice, Korean importer's business license.

Personal protective mask standards: KF (Korean filter) series are divided into KF80, KF94, KF99

The regulatory threshold for medical device access in South Korea is basically classified into Class I, II, III, and IV. The certificate holders must be Korean companies, and Korean consignees need to register import qualifications with the Korean Food and Drug Administration in advance.


Australia

Necessary information: bill of lading, packing list, invoice.

It must be registered with the Australian TGA and comply with the standard specification: AS/NZS 1716:2012, which is the respiratory protective device standard for Australia and New Zealand.

TGA is the Therapeutic Goods Administration, which is the regulatory body for therapeutic goods (including drugs, medical devices, gene technology and blood products) in Australia. Australia divides medical devices into Class I, Is and Im, IIa, IIb, and III. The classification of products is almost the same as that of the EU. If the product has obtained the CE mark, the product category can be classified according to CE.



The quality issues of medical supplies are more concerning than product quality issues in other fields, and the reason is self-evident.

For us, we should have strict requirements on the quality and quantity of exported medical products. If quality problems are true, the relevant companies must be severely punished according to law.


We also hope that sellers can abide by business rules, meet export conditions, and be prepared for export.


Source: SellerGrowth

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