The new coronavirus is on the verge of causing a global pandemic, said world health organization (who) director-general tandesay tandesay at a recent press conference. The number of new cases of pneumonia is on the rise globally, with more than 32,000 cases confirmed outside China, according to data released by the world health organization Thursday. Among them, 7755 cases of new crown pneumonia were confirmed in South Korea. A total of 8,042 new cases of pneumonia have been confirmed in Iran. More than 10,000 new cases of pneumonia have been confirmed in Italy. The total number of confirmed cases of new crown pneumonia in Spain has reached 1,695, and the total number of confirmed cases in the United States has exceeded 1,000...

As the global epidemic continues to spread, supplies such as face masks have been sold out around the world, leading to shortages and panic buying in several countries hit hard by the outbreak. In response to this situation, countries around the world began to adopt the control of medical supplies such as masks, at the same time, many countries announced that they will resume the import of medical supplies such as masks from the Chinese market.


So far, the Chinese customs has not banned or restricted the normal export of protective materials such as protective clothing and masks. Moreover, the state ministry of industry and information technology has explicitly encouraged the export of protective clothing, masks and other materials.


As the situation of preventing and controlling the new pneumonia epidemic in China continues to improve, according to the latest data of the national development and reform commission, the daily production of masks in China can reach 110 million and the daily production is 116 million. The problem of masks in China has been greatly alleviated, which means that China has enough capacity to export masks abroad.

Cao xuejun, deputy director general, said at a recent press conference that China is not only a major producer of epidemic prevention materials, but also a responsible country. In the face of global crises and disasters, China should also lend a helping hand to other countries while ensuring domestic demand for materials such as medical protective clothing. An enterprise exporting epidemic prevention materials such as masks and protective clothing for sale shall have the right to import and export, and the business scope shall include the business license for medical devices. At the same time, the export of foreign countries also need to pass the local certification of the destination country, and the export products must meet the local standards. For the export of products purchased as gifts or on behalf of others, relevant qualification documents of purchasers and manufacturers shall be provided.


In view of the different countries on the import of related products of the qualification requirements are different, the global textile network xiaobian finishing some medical supplies such as masks export need to pay attention to some matters, specifically summarized as follows:


I. what qualifications and materials do domestic exporters need?

1. Business license (the business scope has relevant business contents).

2. Enterprise production license (required by the factory).

3. Product inspection report (factory self-inspection).

4. Medical device registration certificate (non-medical items are not required).

5. Product specification (provided with the product), label (provided with the attached product).

6. Product batch/number (outer packing).

7. Product quality and safety book (provided with the product).

8. Pictures of product samples and outer packing.

9. Trading companies need customs registration.

* whether it is medical grade or not, it shall be determined by the food and drug administration according to the product qualification and standards! See article 5.


2. Can the epidemic materials such as masks be exported?

Answer: the ministry of commerce has stated that the epidemic materials such as masks can be exported normally. So all about the mask can not export rumors are false, refute rumors!


Iii. What qualifications do enterprises exporting epidemic materials need?

Answer: the epidemic disease material that is not medical instrument management such as ordinary face mask, do not have supervisory condition, the enterprise that has import and export authority, can export directly. Three certificates are required for the licensed epidemic materials such as masks:

A. Business license (the business scope includes medical devices, non-medical items are not required.

B. Product registration certificate or registration certificate. Non-medical items are not required.

C. Factory test report, and then export to enterprises with import and export right. In addition, if the enterprise wants to donate or replace the overseas affiliate to purchase, it needs to provide information.


Four, in our company want to export a batch of certificate - related masks, but there is no export qualification, I want to ask can also export?

Answer: if it is the product of the factory with three certificates, you can sell it through the agent by contacting us. If there is no three certificates, it cannot be exported.


Five, ordinary mask and medical mask export need what qualification respectively, need to deal with what card?

Answer: general and medical, it is to point to use. And administration of food and drug administration is according to product quality and standard to manage. Masks of class ii and class iii medical equipment shall be exported only after they are registered or registered.


Six, the trade company does not have the qualification of medical apparatus and instruments, can you export mask, the manufacturer can offer 3 card, drawback has a problem?

Answer: ok, the business scope of foreign trade company had better include the content such as labor protection article. The manufacturer provides three license can export drawback.


Seven, I think personal express a small number of masks can be sent to foreign countries?

Answer: personal postal service is not prohibited to export at present. General express in the United States, you can consider FEDEX, UPS, DHL, EMS, SF and other express companies. However, some people reported that DHL would require the sender to provide the FDA certification of the United States, while some DHL simply refused to accept, and some partners were rejected by FEDEX. That can try post office mail to try first, or before mailing, first telephone to consult each express company.


Eight, how to check whether the mask is qualified?

Answer: go to the official website of the national medical products administration (www.nmpa.gov.cn) and then click on the section of "medical devices" -- "home-made devices". According to the instructions on the page, enter the medical device registration certificate number or enterprise name of this mask, you can know the production information related to the product, the approval number information, you can know whether qualified.


Nine, excuse me if mask wants to export to Korea, what data does local import need and apply for what attestation?

Answer: Chinese exporter and Korean importer prepare necessary documents: bill of lading, packing list and invoice.

Necessary qualification of Korean importer business license of Korean importer.

Necessary preparatory work for Korean importers: need to go to Korea Pharmaceutical Traders Association of Korea food and drug administration. Register import qualification in advance (no problem) website: www.kpta.or.kr.

Note: if the enterprise USES for itself and receives gifts, it can import by itself.

For masks and other goods to have a detailed origin identification, if it is Made in China must have a label: Made in China, manufacturer information, shelf life, but also prepare ingredient content description, manufacturing process.

Finally, we also need the goods to Korea after the test to send samples to the laboratory, test qualified before entering the Korean market distribution.


Excuse me, if the mask is to be exported to Japan, what materials are needed for local import and what certification are applied for?

Answer: Chinese exporter and Japanese importer prepare necessary documents: bill of lading, packing list and invoice.

Foreign manufacturers must register their manufacturer information with PMDA

PMDA, a medical-device company that exports to Japan, has to meet the requirements of Japan's Pharmaceutical and Medical Device Act (PMD), a requirement for TOROKU's registration system, to get its products into the Japanese market.

Mask packaging requirements:

Printed on the packaging ウ ィ ル ス カ ッ ト (translation: viruses interception) 99% of the words PFE: 0.1 um particles particle filtration efficiency

BFE: bacterial filtration rate

VFE: virus filtration rate

Mask quality standard:

1. Medical respirator: it meets the mandatory standard of China GB 19083-2010, and its filtration efficiency is ≥ 95% (non-oily particulate test is used).

2. N95 mask: us NIOSH certified, non-oily particulate filtration efficiency ≥ 95%.

3. KN95 mask: it meets the mandatory standard of GB 2626 in China, and the filtration efficiency of non-oily particles is ≥ 95%.

11. If the mask is to be exported to the United States, what materials are required for local import and what certification are required?

Answer: Chinese exporters and American importers prepare the necessary documents: bill of lading, packing list and invoice.

Masks imported from the United States must be approved by the FDA if they are to be sold.

Masks for

According to HHS regulations, NIOSH classifies its certified particulate respirators into nine categories. The certification is carried out by NIOSH's NPPTL laboratory.

In the United States, masks can be divided into three grades -- N, R, P -- according to the lowest filtration efficiency of the filter material.

Class N masks can only filter non-oily particles, such as: dust, acid fog, paint fog, microorganisms, etc. Aerosols in air pollution are also mostly non-oily.

R mask is only suitable for filtering oily particles and non-oily particles, but the time limit for oily particles should not exceed 8 hours.

Class P mask can filter both non-oily particles and oily particles. Oily particulate matter such as: lampblack, oil mist.

According to the difference of filtration efficiency, there is another difference of 90,95,100, which refers to the minimum filtration efficiency of 90%, 95% and 99.97% under the standard test conditions.

N95 is not a specific product name. Products that meet the N95 standard and are approved by NIOSH are considered N95 masks.


12. If the mask is to be exported to the European Union, what materials are needed for local import and what certification are applied for?

Answer: Chinese exporters and American importers prepare the necessary documents: bill of lading, packing list and invoice.

Masks for

All masks exported to the eu must obtain a CE certificate under the new regulations.

CE is the product safety certification for export to the European Union. The word CE is abbreviated from the French "Communate Europpene", which means European Community. The European Community later evolved into the European Union (eu). In the eu market "CE" mark is a compulsory certification mark, whether it is the products produced by enterprises within the eu, or products produced by other countries, in order to free circulation in the eu market, must be affixed with "CE mark".


13. If the mask is to be exported to Iran, what materials are needed for local import and what certification are applied for?

Answer: we need to apply for COI certification in Iran, which means compliance verification in Chinese, and it is the relevant inspection required by Iran's compulsory shipment.


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