Recently, The Export Of Medical Materials Such As Masks Has Been Tightened Up. Summary Of The Latest Masks Export Problems

According to the latest real-time statistical data from the World Health Organization, there are 1699595 confirmed cases of new crown pneumonia worldwide, 106138 deaths, and 1 million 610 thousand cases outside China. With the global epidemic situation becoming more and more serious, more and more medical materials manufactured in China go abroad.

To this end, the Chinese customs strengthened supervision over the export of medical supplies: in March 31st, the Ministry of Commerce, the General Administration of customs and the State Administration of Drug Administration issued the fifth announcement. In April 10th, the General Administration of Customs issued the Announcement No. fifty-third, emphasizing the need to standardize the export order of medical materials and severely crack down on the export of unqualified medical materials.

Then how does the customs ensure the orderly export of medical materials? On April 13th, at the press conference of the joint defense and joint control mechanism of the State Council, Jin Hai, director general of the comprehensive business division of the Customs General Administration, made relevant answers to this question. He said that the quality and safety of medical materials directly related to people's life and health. The customs resolutely implemented the decision and deployment of the Party Central Committee and the State Council, strengthened supervision and management, optimized services, and supported qualified and reputable enterprises to export orderly, so as to create a good customs environment for medical materials to go abroad and support the international community to fight against the epidemic situation together. According to statistics, in from April 1st to 12th, the total value of the main export control materials was 16 billion 560 million yuan.

Jin Hai said that since the announcement of the fifth announcement, the Customs has intercepted about 33000000 medical materials from non list enterprises or registered products without medical device products, including 31 million 650 thousand masks, 509 thousand protective clothing, 1 million 189 thousand new crown virus detection reagents, 677 ventilators, and 46 thousand infrared thermometers. The customs shall strictly investigate and punish the customs according to the regulations, and expose them through the information platform such as "customs release".

According to the Announcement No. fifty-third of the General Administration of customs, the customs will perform the statutory inspection duties of medical materials in accordance with the law, and carry out export commodity inspection for medical masks, medical protective clothing and other medical materials that are directly used for medical treatment of epidemic diseases and closely related to human health and safety. Jinhai emphasizes that enterprises must strictly fulfill the duty of truthfully declaring when exporting medical materials. If the Customs fails to export goods that have been inspected unqualified, or exports goods adulterated with adulteration, adulterated goods, and inferior commodities, and improperly qualified commodities, they will be ordered to stop export, confiscate illegal earnings, confiscate export commodities and fines according to the regulations, and shall be investigated for criminal responsibility in accordance with the law.

Jinhai specially stated that the normal customs declaration of the truthful declaration and the export of qualified medical materials will not be affected. The customs will continue to provide customs clearance facilities. For illegal and dishonest enterprises, the customs will intensify the exposure, and increase the inspection ratio, increase the frequency of checking and checking, and carry out more stringent regulatory measures such as multi disciplinary joint disciplinary measures, so that those who break the law will not be able to walk. We must resolutely safeguard the good order of our medical supplies export.

Are all export masks checked by law?

The export of medical masks belongs to the commodities of legal inspection. Is it necessary to apply for electronic ledger before customs declaration?

When the masks are exported, which documents are required to be submitted for customs declaration?

Are non medical masks belonging to export statutory inspection products? What are the special requirements for customs declaration?

Export masks are medical masks, but not for medical institutions, but for employees or consumers. Can they be declared "non medical"?

At present, many enterprises still have doubts about the hot issues of the global textile network Xiaobian comprehensive enterprise.

01

Are all export masks checked by law?

In order to strengthen the quality supervision of medical materials export, in April 10, 2020, the General Administration of Customs issued a Notice No. fifty-third to carry out export commodity inspection for medical masks. For details, please refer to the customs official announcement: confirm that medical materials such as respirators are listed as export inspection today. "

Be careful! Only when the above HS codes are used, will medical products be inspected by export law, and non medical inspection is not carried out.

02

The export of medical masks belongs to the commodities of legal inspection. Is it necessary to apply for electronic ledger before customs declaration?

Unlike other export inspection products, the 11 categories of medical materials added to the list of legal inspection are newly added. There is no need to apply for electronic ledger before export, declare to customs normally, do not need to provide electronic bottom account when declaring. Of course, there is no need for inspection of origin.

03

When the masks are exported, which documents are required to be submitted for customs declaration?

According to the classified catalogue of medical devices (No. 104th of the State Food and Drug Administration announcement 2017), medical masks belong to two kinds of medical devices. When declaring the customs, it is necessary to provide medical device registration certificate and export medical materials declaration according to the requirements of the Ministry of Commerce, the General Administration of customs and the State Drug Administration on the orderly export of medical materials (2020 No. fifth).

04

Are non medical masks belonging to export statutory inspection products? What are the special requirements for customs declaration?

Non medical masks do not belong to export statutory inspection products. When they are declared, they do not need to provide medical device product registration certificates and declaration of quality and safety commitments. Export enterprises should declare truthfully.

05

Export masks are medical masks, but not for medical institutions, but for employees or consumers. Can they be declared "non medical"?

May not. Determining whether a medical mask is based on the nature of the commodity rather than on the final purpose. Please export enterprises to pay attention to avoid mistakes because they do not know the relevant requirements.

06

When exporting, how do you distinguish between medical and non medical masks?

It can be distinguished according to the relevant standards of masks in China and abroad.

The customs inspection department will update the technical regulations and standards of epidemic prevention materials in some countries or regions from time to time, and has been updated to the third edition. The link is: http://sjs.customs.gov.cn/sjs/zcfg56/2951967/index.html.

Friendship tips

GB2626, KN90, KN95, KN100, KP90, KP95, KP100 and other masks are all non medical masks. Respirators with respirators are also non medical masks. The NIOSH certified N95 mask is not equivalent to the medical respirator.

To distinguish medical non medical masks in detail, we can see links: "how to distinguish medical non medical masks". In addition, the customs inspection and Quarantine Bureau will organize personnel to continue to study and interpret the protective clothing, goggles and other medical and non medical materials.

07

What are the contents of medical masks when they are exported?

The forty-fourth provision of the regulations on the supervision and administration of medical devices stipulates that the enterprises that export medical devices shall ensure that their export medical devices conform to the requirements of the importing countries (regions).

Article sixth of the commodity inspection law stipulates that the inspection of import and export commodities that must be implemented refers to the conformity assessment activities that determine whether the import and export commodities listed in the catalog conform to the mandatory requirements of the state technical specifications. Conformity assessment procedures include: sampling, inspection and inspection; assessment, validation and qualification assurance; registration, accreditation and approval, and combinations.

When the medical mask is exported, the customs shall conduct on-site conformity assessment according to the wind control instruction.

A. verify whether the actual goods are consistent with the medical device registration certificate.

B. inspection of commodity packaging, identification, name, quantity, and whether it is fraudulent or false.

C. evaluate the quality and safety undertaking (quality assurance) or testing report submitted by the enterprise.

D. inspection of merchandise appearance quality inspection;

E. sampling is sent to the laboratory to test the intrinsic quality of the products.

F....

08

What are the requirements of bilateral medical products for export?

According to the bilateral agreement signed between Chinese and foreign governments, the masks currently exported to the 4 countries are required to apply for pre shipment inspection. In conformity with the scope of pre shipment inspection, inspection of origin and port inspection shall be carried out according to the requirements of the export inspection before the goods, and a pre shipment inspection certificate will be issued by the customs.

09

Which entry requirements should be paid attention to when exporting masks?

Different countries have different requirements for imported masks. For example, the United States needs FDA registration for imported medical masks, and the EU has obtained CE certification for the import of non medical masks. Specific requirements refer to: "customs authority release: Guidebook export clearance trade measures guide".

Ten

What administrative penalties will be imposed on undeclared or unauthorized medical masks?

If a medical material is falsely reported as a non medical material for evading inspection, or a general commodity in a category C express is falsely reported as an advertisement for goods samples, it shall be severely punished according to law. If a suspected crime constitutes a crime, it shall be transferred to the local public security organ for criminal responsibility.

If the export is a product adulterated with adulteration, adulterated or adulterated, or impersonated as a qualified import and export commodity with unqualified import and export commodities, it shall be ordered to stop the export, confiscate the illegal gains and impose a fine of fifty percent or more than three times the value of the goods. If a crime is constituted, it shall be investigated for criminal responsibility in accordance with the law.

Eleven

The following is a rumor about the export of masks.

Export anti epidemic materials do not violate the regulations.

Customs reminder

If it is found that there are false concealment, entrainment, adulteration, adulteration, adulteration, or illegal act of passing off the epidemic prevention and control materials, the customs will deal with it strictly according to the law.