Export Trade Instructions: Detailed Answers To The Precautions For The Export Of Medical Materials Such As Masks!

Recently, Director General of the World Health Organization Tan Desai said at a news conference that the new coronavirus is close to causing a global pandemic. According to the data released by the World Health Organization on the 10th, the number of confirmed cases of COVID-19 continues to rise worldwide, with more than 32000 confirmed cases of COVID-19 outside China. Among them, there were 7755 confirmed cases of COVID-19 in South Korea; There were 8042 confirmed cases of COVID-19 in Iran; The cumulative number of confirmed cases of COVID-19 in Italy has exceeded 10000; The cumulative number of confirmed cases of COVID-19 in Spain has reached 1695, and the cumulative number of confirmed cases of COVID-19 in the United States has exceeded 1000

With the continuous spread of the global epidemic, epidemic prevention materials such as masks have been out of stock around the world, and many countries with serious epidemic situations have experienced a shortage of epidemic prevention materials and a rush to buy them. In response to this situation, countries around the world began to control medical materials such as masks. At the same time, many countries announced that they would resume importing medical materials such as masks from the Chinese market.

At present, the situation of prevention and control of COVID-19 epidemic in China continues to improve. According to the data announced by the National Development and Reform Commission, on February 29, the national daily production of masks, including ordinary masks, medical masks, and medical N95 masks, reached 110 million, and the daily production reached 116 million, 5.2 times and 12 times higher than that on February 1, respectively. At present, the domestic mask problem has been greatly alleviated, This means that China has enough capacity to export masks abroad.

In view of the urgent shortage of overseas markets, the export of masks will become a new profit growth point for domestic enterprises, but what should be paid attention to in the export of medical materials such as masks? Global Textile Network has summarized relevant issues as follows:

1、 What qualifications and materials do domestic exporters need?  
1: Business license (business scope has relevant business content).
2: Enterprise production license (required by the factory).
3: Product inspection report (factory self inspection).
4: Medical device registration certificate (not required for non medical items).
5: Product manual (provided with the product), label (provided with the product).
6: Product batch/number (outer package).
7: Product quality safety certificate (provided with the product).
8: Product sample pictures and outer package pictures.
9: Trading companies need customs registration.
*Whether it is medical grade or not shall be determined by the Food and Drug Administration according to product qualification and standards! See Article 5 for details.

2、 Can domestic epidemic materials such as masks be exported at present?
Answer: The Ministry of Commerce has explained that masks and other epidemic materials can be exported normally. So all the rumors about that masks cannot be exported are false!

3、 What qualifications do enterprises exporting epidemic materials need?
Answer: Ordinary masks and other epidemic materials not managed by medical devices can be directly exported by enterprises with import and export rights without supervision conditions. Medical masks and other epidemic materials involving certificates need three certificates:
A. Business license (the business scope includes medical devices, and non medical items are not required.
B. Product filing certificate or registration certificate. Non medical items are not required.
C. The manufacturer's inspection report, and then the enterprises with import and export operation rights can export. In addition, if the enterprise wants to give gifts or purchase on behalf of overseas affiliates, it needs to provide information.

4、 In our company, we want to export a batch of masks related to certificates, but we don't have export qualification. Would you like to ask if we can export them?
Answer: If it is the product of a factory with three certificates, you can contact us for export sales through an agent. If it does not have three certificates, it cannot be exported.

5、 What qualifications and certificates are required for the export of ordinary masks and medical masks?
Answer: Ordinary and medical use refer to use. The administration of the Food and Drug Administration is based on product quality and standards. The masks of Class II and Class III medical instruments can only be exported with the filing certificate or registration certificate.

6、 The trading company does not have the qualification of medical devices. Can it export masks? The manufacturer can provide three certificates. Is there any problem with tax refund?
Answer: Yes, the business scope of a foreign trade company should preferably include labor protection articles. The manufacturer provides three certificates for export tax rebate.

7、 Can I send a small number of masks abroad by personal express?
Answer: The export of personal mail is not prohibited at present. For general express delivery in the United States, FEDEX, UPS, DHL, EMS, SF and other express companies can be considered. However, some people reported that DHL would ask the sender to provide the FDA certification of the United States, some DHL simply refused, and some partners were rejected by FEDEX. You can try the post office mail first, or consult each express company by phone before mailing.

8、 How to check whether the mask is qualified?
Answer: Log in to the official website of the "State Drug Administration" (www.nmpa. gov.cn), and then click the column "Medical Devices" - "Domestic Devices". According to the instructions on the page, enter the medical device registration certificate number or enterprise name of the mask to know the production information of the enterprise related to the product, and the approval number information to know whether it is qualified.

9、 If the mask is to be exported to South Korea, what information will be required for local import and what certification will be applied for?
Answer: The Chinese exporter and the Korean importer prepare the necessary materials: bill of lading, packing list and invoice.
The Korean importer must have the business license of the Korean importer.
The Korean importer must make preparations: go to the Korea Pharmaceutical Traders Association of the Korean Drug Administration Filing import qualification in advance (not necessary) Website: www.kpta.or.kr 。
Note: In case of self use and donation, the enterprise can import on its own without relevant qualification.
For products such as masks, there should be detailed identification of origin. If they are made in China, there must be labels: Made in China, Manufacturer information, shelf life, ingredient content description and manufacturing process flow shall also be prepared.
Finally, after the goods arrive in South Korea, they need to carry out fine supervision tests and send samples to the laboratory. Only after the tests are qualified, can they enter the South Korean market for sales and circulation.

10、 If the mask is to be exported to Japan, what information will be needed for local import and what certification will be applied for?
Answer: The Chinese exporter and the Japanese importer prepare the necessary materials: bill of lading, packing list and invoice.
Foreign manufacturers must register manufacturer information with PMDA
PMDA registered medical device companies exporting to Japan want to put their products on the Japanese market must meet the requirements of the Pharmaceutical and Medical Device Act (PMD Act) in Japan. Under the requirements of PMD Act, TOROKU registration system requirements.
Respirator packaging requirements:
99% words printed on the package PFE: 0.1um particulate particle filtration efficiency
BFE： Bacterial filtration rate
VFE： Virus filtration rate
Quality standard of mask:
1. Medical protective respirator: comply with the mandatory standard of China GB 19083-2010, and the filtration efficiency is ≥ 95% (tested with non oily particles).
2. N95 respirator: American NIOSH certification, with filtration efficiency of non oily particles ≥ 95%.
3. KN95 respirator: meet the mandatory standard of China GB 2626, and the filtration efficiency of non oily particles is ≥ 95%.

11、 If the mask is to be exported to the United States, what information will be required for local import and what certification will be applied for?
Answer: The Chinese exporter and the US importer prepare the necessary materials: bill of lading, packing list and invoice.
If masks imported from the United States need to be sold, they must obtain FDA certification.
Mask requirements
According to HHS regulations, NIOSH classifies its certified anti particle respirators into 9 categories. The specific certification is operated by NPPTL laboratory under NIOSH.
In the United States, masks can be divided into three grades according to the minimum filtration efficiency of filter material - N, R ,P。
Class N masks can only filter non oily particles, such as dust, acid mist, paint mist, microorganisms, etc. The suspended particles in air pollution are also mostly non oily.
R respirator is only suitable for filtering oily particles and non oily particles, but the use time for oily particles shall not exceed 8 hours.
Class P mask can filter both non oily particles and oily particles. Oily particles such as oil smoke, oil mist, etc.
According to the different filtration efficiency, there are also 90,95100 differences, which respectively mean that the minimum filtration efficiency is 90%, 95% and 99.97% under the test conditions specified in the standard.
N95 is not a specific product name. As long as the product meets the N95 standard and passes the NIOSH review, it can be called "N95 respirator".

12、 If the mask is to be exported to the EU, what information will be required for local import and what certification will be applied for?
Answer: The Chinese exporter and the US importer prepare the necessary materials: bill of lading, packing list and invoice.
Mask requirements
All masks exported to the EU must obtain CE certification under the requirements of the new regulations.
CE origin CE certification is the product safety certification exported to the EU, The word CE is abbreviated from "Communate Europene" in French, which means the European Community. The European Community later evolved into the European Union (EU for short). The "CE" mark is a compulsory certification mark in the EU market. Whether products produced by enterprises within the EU or products produced in other countries, they must be affixed with the "CE mark" if they want to circulate freely in the EU market.

13、 If the mask is to be exported to Iran, what information will be required for local import and what certification will be applied for?
Answer: It is required to apply for COI certification in Iran. The Chinese version is compliance verification, which is related to Iran's mandatory import shipment requirements.

14、 Our enterprise needs foreign trade agency; Export customs clearance services; How to contact you for export booking service.
Answer: Please call the customer service hotline: 400-119-0123, and we will try our best to answer the question for you.