Export Trade Tips: Masks And Other Medical Supplies Exports Need To Pay Attention To Detailed Answers!

Recently, WHO director general Tan Desai said at a news conference that the new coronavirus was close to causing the global pandemic. According to data released by WHO 10, the number of confirmed cases of new crown pneumonia continues to rise, and the number of confirmed cases of new crown pneumonia outside China exceeds 32000. Among them, 7755 cases were confirmed by new crown pneumonia in South Korea, 8042 cases were confirmed by new crown pneumonia in Iran, and ten cases were confirmed by new crown pneumonia in Italy. 1695 cases were confirmed by the new crown pneumonia in Spain, and 1000 cases were confirmed by the new crown pneumonia in the United States.

With the continuous spread of the global epidemic, masks and other anti epidemic materials have been out of stock around the world. There are many shortages of epidemic prevention materials and panic buying in many countries with serious epidemic situation. In response to this situation, countries around the world have begun to control medical supplies such as masks, while many countries have announced that they will resume imports of medical products such as masks from the Chinese market.

At present, China's new crown pneumonia epidemic prevention and control situation continues to improve, according to the national development and Reform Commission announced data, in February 29th, including masks, medical masks and medical N95 masks, the national masks can reach 110 million Nissan, with a daily output of 116 million, which is 5.2 times and 12 times that of February 1st. It has the capacity to export masks to foreign countries.

In view of the urgent shortage of overseas market, masks export will become a new profit growth point for domestic enterprises. But what should we pay attention to when exporting medical materials such as masks? The global textile network Xiaobian has summarized relevant issues as follows:

1. What qualifications and materials do domestic export traders need? ?
1: business license (business scope has related business content).
2: enterprise production license (factory need).
3: product inspection report (factory self inspection).
4: medical device registration certificate (non medical grade items do not need).
5: product description (followed by product), label (supplied with products).
6: product batch / number (outer package).
7: product quality safety book (followed by product).
8: product sample picture and package picture.
9: trade companies need customs registration.
* whether it is medical level, determined by the drug administration according to the product qualification and standards. For details, see fifth.

Two, is current domestic masks and other epidemic materials exportable?
Answer: the Ministry of Commerce has explained to the outside world that materials such as respirators can be exported normally. So all the rumors about masks can not be exported are false.

Three, what qualifications do enterprises need to export epidemic materials?
Answer: unauthorized medical devices, such as general masks, do not have regulatory requirements. Enterprises with the right to import and export can export directly. Products such as masks and other epidemic related products require three products:
A. business license (business scope includes medical device related, non medical grade items do not need.
B. product registration certificate or registration certificate. Non medical grade items are not required.
C. factory inspection report, and then have the right to import and export enterprises, and then export. In addition, if enterprises want to give or replace overseas affiliates, they need to provide details.

Four, our company wants to export a number of certificate masks, but there is no export qualification. Would you like to ask for export?
Answer: if it is a product with three certificates, it can be exported through the agent through contact with us. If there are no three cards, it can not be exported.

Five, what kind of qualification is required for the export of masks and medical masks?
Answer: general and medical, refers to the purpose. The management of the drug administration is managed according to the quality and standards of the products. The masks of two and three types of medical devices need to be registered or registered before they can be exported.

Six, trading companies do not have the qualification of medical devices, can they export masks? Manufacturers can provide three certificates. Is there any problem with tax rebates?
Answer: Yes, the business scope of the foreign trade company preferably includes labor protection supplies and so on. The manufacturer provides three certificates for export tax rebates.

Seven, I would like to send a small number of personal masks to foreign countries can send it?
Answer: personal mail is not prohibited at present. General express the United States, you can consider FEDEX, UPS, DHL, EMS, SF and other courier companies. However, it has been suggested that DHL will require the sender to provide the FDA certification of the United States, and some DHL simply refuse to accept it, and a small partner has been rejected by FEDEX. You can try the post office mail first, or call the couriers before calling.

Eight, how to check whether the respirator is qualified?
Answer: log on to the official website of the www.nmpa.gov.cn, then click the "medical device" - "domestic equipment" column. According to the page instructions, enter the medical device registration certificate number or enterprise name of the mask, then you can know the production information related to the product and approve the information of the number, then you can know if it is qualified.

Nine. If the mask is to be exported to Korea, what information does the local import require and what certification is required?
Answer: Chinese exporters and importers of Korea prepare necessary information: bills of lading, boxes, invoices.
The importers of Korea must be qualified as the South Korean importer's business license.
The importers in South Korea must prepare for the work: they need to go ahead with the Korea Pharmaceutical Traders Association. of Korea for the record of import qualification.
Note: enterprises are self provided and can import their own products without qualification.
For masks and other commodities, there must be a detailed origin mark. If it is made in China, there must be a label: Made in China, manufacturer's information, shelf life, and preparation of component content description, manufacturing process.
Finally, it is necessary for the goods to be sent to the laboratory after being sent to South Korea for testing. After testing, they can enter the Korean market for sale and circulation.

Ten. If the mask is to be exported to Japan, what information does the local import require and what certification is required?
Answer: Chinese exporters and importers of Japan prepare necessary information: bills of lading, boxes, invoices.
Manufacturers abroad must register manufacturer information with PMDA.
PMDA registered medical device companies exporting to Japan want to put their products in the Japanese market. We must meet the Pharmaceutical and Medical Device Act (PMD Act) in Japan, and request the TOROKU registration system at the request of PMD Act.
Mask packaging requirements:
The packaging is printed with the word "PFE:0.1um" particle filtration efficiency of 99%.
BFE: bacterial filtration rate
VFE: virus filtration rate
Quality standards for respirators:
1. medical respirator: in line with China's GB 19083-2010 mandatory standard, filtration efficiency of more than 95% (using non oil particle test).
2. N95 respirator: NIOSH certification in the United States, non oil particulate matter filtration efficiency of more than 95%.
3. KN95 respirator: in line with China's GB 2626 mandatory standard, non oily particulate matter filtration efficiency of more than 95%.

Eleven. If the mask is to be exported to the United States, what information does the local import require and what certification is it applied for?
Answer: Chinese exporters and importers of the United States prepare necessary information: bills of lading, boxes, invoices.
The masks imported from the United States must be certified by FDA if they need to be sold.
Mask requirements
According to HHS (US Department of health and public service) regulations, NIOSH (National Institute of occupational safety and health) divided its certified particulate respirators into 9 categories. The specific authentication is operated by the NPPTL laboratory affiliated with NIOSH.
In the United States, according to the minimum filtration efficiency of filter material, the respirator can be divided into three grades -- N, R, P.
Respirators of class N can only filter non oily particles, such as dust, acid mist, paint mist, microorganism and so on. The suspended particulates in air pollution are also non oily.
The R respirator is only suitable for filtering oily and non oily particles, but when used for oily particulate matter, it can not be used for more than 8 hours.
P respirators can filter non oily particles and filter oily particles. Oily particles such as lampblack, oil mist, etc.
According to the difference of filtration efficiency, there is also the difference between 90,95100, which means that the minimum filtration efficiency is 90%, 95%, 99.97% under the standard test conditions.
N95 is not a specific product name. As long as the N95 standard is met, and the products examined by NIOSH can be called "N95 mask".

Twelve. If the mask is to be exported to the European Union, what information does the local import require and what certification is required?
Answer: Chinese exporters and importers of the United States prepare necessary information: bills of lading, boxes, invoices.
Mask requirements
All masks exported to the EU must obtain CE certification under the requirements of the new regulations.
CE CE certification is the product safety certification for export to the European Union. The word "CE" is abbreviated from the French "Communate Europpene" and is the meaning of the European community. The European Community later evolved into the European Union (EU). In the EU market, the "CE" logo is a mandatory certification mark, whether it is products produced by the European Union enterprises or products produced by other countries, if we want to freely circulate in the EU market, we must add the "CE logo".

Thirteen. If the mask is to be exported to Iran, what information does the local import require and what certification is required?
Answer: we need to apply for COI certification in Iran. Chinese is a compliance check. It is a relevant inspection of Iran's compulsory import requirements.

Fourteen, our enterprises need foreign trade agents; export customs clearance services; export booking services how to contact you.
Answer: please call customer service hotline: 400-119-0123, we will do our best to answer for you.