As of March 7, 2020, we compiled the latest analysis of the global epidemic situation of coronavirus and the shortage of masks due to the epidemic of coronavirus.

 

In this blog, you can learn about the latest Chinese government’s latest regulations, policies on importing masks from China. Of course, the policy changes at any time.  Importing masks from China must keep in touch with suppliers in a timely manner. Take the latest Chinese government policy.

 

This blog will guide you to learn how to find a Chinese mask supplier, how to control masks quality the risk of importing masks, the classification of common masks, logistics options for importing masks from China. Documents and certificates required for import clearance for masks, as well as a summary of common problems, from Chinese suppliers and overseas mask importers.

 

This blog can give you a good inspiration and help, we hope the global coronavirus epidemic ends soon.

 

 

China has suffered a period of self-quarantine for 3 weeks. At present, this coronavirus epidemic has been brought under apparent control! But the virus was not completely controlled, but began to spread rapidly in the international arena!

 

At present, with the development of time, the epidemic situation in many countries has reached an uncontrollable level! As a result, the demand for imported masks has increased rapidly in various countries.

 

 

Use Bestforworld’s logistics services to ensure that your medical protection supplies are safe and reach your destination in a timely manner.  Stop using CIF high and opaque shipping costs.

 

 

 

 

 

Here are the basics of several major outbreak countries:

 

 

Coronavirus outbreak in South Korea

 

South Korea ’s Central Epidemic Prevention Department reported on the 28th that, as of 9:00 am on the 28th 2020 local time, South Korea had added 256 new cases of new coronavirus from the previous day at 4 pm, with a total of 2022 confirmed cases. The number of infections in South Korea continues to rise, but the honest act of the Korean government to dare to disclose the actual numbers of the outbreak is admirable.

 

The South Korean government has designated Daegu and Gyeongbuk as special control areas, saying that it will take super-strong “blockade measures” to prevent the spread of the epidemic, but the growth trend still shows no signs of containment!

 

At present, the US-ROK joint military exercise has been canceled, and the United States has even closed its military base in South Korea!

 

In early February, Bestforworld logistics helped the Hubei Chamber of Commerce in China import 300,000 masks of the Korean KF94 standard and imported them by air from South Korea to China. But unexpected that in less than half a month, the outbreak in South Korea was so rapid that the lack of domestic masks.

 

These days we have received many emails, text messages, and inquiries from Korean customers and friends, how to buy medical from China to the Korean market. We will mention later how to import masks from China and how to buy masks from China.

 

 

 

Coronavirus outbreak in Japan

 

As of 8 am on February 28th, 2020 local time, a total of 919 new Japanese coronavirus patients had been infected, including 200 infected people in Japan, 705 passengers and flight attendants of the “Diamond Princess” cruise ship, and the Japanese government Fourteen charter flights returned to Japan.

 

Tokyo Disneyland management announced that Tokyo Disneyland and DisneySea will be temporarily closed, tentatively closed to March 15.

The outbreak in Japan is also rising.

 

 

 

Coronavirus outbreak in Italy

 

In addition to Japan and South Korea, Italy is also the hardest hit area! According to data released by the Italian Ministry of Health, the country added 147 new confirmed cases of new coronavirus on the 26th. As of 00:00 on the 27th local time, a total of 470 cases of the coronavirus infection have been confirmed in Italy, and a total of 12 deaths have been confirmed. Neighboring Greece, North Macedonia and other European countries have confirmed cases for the first time on the 26th. Patients have recently visited Italy.

 

Currently, more than 20 countries have adopted measures such as restricting entry, banning travel, and suspending flights to Italy.

 

Many Chinese businessmen doing business in Italy have recently returned to China, but several passengers have been confirmed to be coronavirus positive on the flight on the Shanghai Pudong airport

 

 

 

Use Bestforworld’s logistics services to ensure that your medical protection supplies are safe and reach your destination in a timely manner.  Stop using CIF high and opaque shipping costs.

 

 

 

Global mask demand and prices are rising wildly:

 

With the uncontrollable development of the global epidemic, the demand and prices of medical protective products such as disposable masks have also increased rapidly!

 

Spanish demand grows 100 times

 

According to the Spanish “Daily Development” website on February 25, 2020, Federation of Pharmaceutical Distributors consists of 9 pharmaceutical associations representing 19 distribution companies, which account for 97% of the Spanish pharmaceutical distribution market. A spokesman for the organization emphasized that the demand for masks experienced “unusual” growth between January 2019 and January 2020, with a growth rate of 10,000%.

 

The report said that the growth in the demand for masks last week remained above 8000%. The organization said on February 24, 2020, that the future development will depend on the impact of the new coronavirus epidemic on Italy.

 

 

 

Korean’ mask prices up 800%

 

At present, the price of online purchases of Korean masks has skyrocketed, with a single price of more than 4,000 KRW (about 3.2 USD).

 

According to data released by the Korean Statistics Agency on the 27th, the online price of KF94 masks recently exceeded 4,000 KRW, which is 6-8 times higher than the pre-epidemic (700-800 KRW). The prices of stores such as drug stores and supermarkets have remained at 2,000 KRW Levels.

 

The Korea Food and Drug Safety Agency previously announced that since the 27th2020, 3.5 million masks have been distributed to the country every day, and sold separately at post offices, pharmacies, agricultural cooperatives, and other places. Each person is limited to 5 at a time. But still in short supply!

 

 

 

 

 

Italian mask prices soar 10,000%

 

With the development of the epidemic in Italy, some merchants in the country have significantly increased their selling prices due to the epidemic. Italian Deputy Prosecutor Tiziana Siciliano said: “The online price of masks has increased from 10 cents to 10 euros, and a bottle of disinfectant with a capacity of one liter was sold last week for 7 euros, and now costs 39 euros.”

 

But even if it is so expensive, masks in some northern supermarkets are almost sold out.

 

 

 

In addition, Amazon, eBay, and other platforms have also appeared on N95 masks priced more than 1,000 US dollars, the price was incredible.

 

 

 

 

 

 

The situation of Chinese mask suppliers and exporters, Until March 7, 2020

 

 

The following content will answer these common questions:

 

Can mask factories in China export masks?

 

How to find a reliable Chinese mask manufacturer?

 

At present, there are many fake masks. If I import masks from China, how can I make sure the authenticity? Control the quality of disposable masks?

 

I am a trading company in the United States. I used to import toys from China. How can I import masks to the United States?

 

I want to import masks from China to the UK. How to arrange international logistics, by sea or by air?

 

Can you provide door-to-door DDU / DDP service from China imported masks to Australia?

 

What documents, certifications, and authorizations are needed for importing masks from China to Germany?

 

How to judge the authenticity of imported Chinese masks, and how to distinguish between three-layer civilian protective masks and medical masks?

 

 

 

 

As a large number of Chinese companies such as the automotive industry and the electrical industry have begun to put on a oduction of mask production lines, they have met the domestic demand for masks, which has led to the current shortage of raw material meltblown cloth.

 

Meltblown cloth can be called the “heart” of surgical masks and N95 masks. Medical-surgical masks and N95 masks generally use a multilayer structure, referred to as the SMS structure: a single layer of spun-bond (S) on the inside and outside, and a meltblown layer (M) in the middle, generally divided into single or multiple layers.

 

Among them, the outer layer is a non-woven fabric with a waterproof treatment, which is mainly used to isolate the droplets sprayed by the patient; the middle melt-blown layer is a specially-treated melt-blown non-woven fabric, which has good filtering and shielding properties. , Thermal insulation and oil absorption, are important raw materials for the production of masks; the inner layer is ordinary non-woven fabric.

 

 

 

At present, due to the scarcity of meltblown cloth, its price has increased from 18,000 RMB to 80,000 RMB, a 4.44 times increase! However, according to some mask suppliers’ words, Even if the raw materials increase, the ex-factory price of the mask cannot rise! Because the masks produced have either been donated or supplied to the government for distribution, prices cannot be increased.

 

Today Until March 7, 2020, the daily output of full-face masks has reached 100 million. I believe that supply and demand will gradually balance! Domestic demand will soon be met, and profitability has become the primary goal of Chinese mask suppliers and exporters. The earliest news is the latest news received by BW on March 5. Although the Chinese government strictly controls domestic mask transactions, it sells them. But China’s mask suppliers and factories and exporters have been allowed to export masks. Because the Chinese government is worried that if the current production progress, China’s masks will be overcapacity.

 

 

 

 

Use Bestforworld’s logistics services to ensure that your medical protection supplies are safe and reach your destination in a timely manner.  Stop using CIF high and opaque shipping costs.

 

 

 

At present, the Chinese government has not explicitly banned the export of masks, but due to the domestic epidemic situation that has not completely slowed down, and fake masks are frequent, customs inspection of this category is still relatively strict from China’s customs.

 

 

 

 

 

 

What qualifications needed to export masks from China?

 

Exporting mask from China (Corporate Action)

 

For overseas sales of masks:

Only those who have a medical device business license in the business scope, and those with import and export rights, can export.

 

Used as a gift or as a purchase mask

As a gift or for purchasing on behalf of an affiliated company (parent-subsidiary, importer), provide relevant certification documents, business license, product medical device filing certificate, manufacturer inspection report.

 

 

 Recently, in Wenzhou, 70 new mask manufacturing companies were established in 5 days. These companies only have manufacturing capabilities, and many companies have not obtained export licenses for medical devices. This is something that importers need to pay attention to. Otherwise, you have purchased Chinese masks, but the goods cannot be exported. Of course, there are ways to find an agency with medical equipment export permit, but you need to pay extra agency export costs. Importers who encounter such issues can contact Bestforworld, and we will assist with similar issues.

 

 

Of course, there are many Chinese mask exporters who use other product names to replace masks in order to avoid customs and platform inspections. This is a very dangerous operation and the risk is very high.

 

 

 

Use Bestforworld’s logistics services to ensure that your medical protection supplies are safe and reach your destination in a timely manner.  Stop using CIF high and opaque shipping costs.

 

 

 

Many sellers who sell surgical masks and N95 maks on Amazon or are about to sell, it is recommended to carry out FDA and other related certifications for masks imported from China, otherwise, they will face investigation and seal risks. Amazon sellers must sell masks legally and compliantly.

 

 

 

In fact, in addition to masks, sellers who know Amazon can also pay attention to products such as forehead thermometers. We have received many shipping inquiries about forehead thermometers.

 

 

In addition, according to the Shenzhen Third Hospital today test: New crown virus nucleic acid was detected in the conjunctival secretions of patients with new coronavirus! Eye discharge infection has been confirmed! Goods such as goggles and ski goggles may also become popular products on Amazon.

 

 

 

 

 

Enter the core content below about importing masks from China or shipping masks from China:

 

 

How to choose a reliable Chinese mask supplier and exporter? risk? Process? The choice of logistics solution?

 

 

For many professional importers of masks and medical supplies, they are not worried about how to find a reliable supplier, because before the outbreak, this type of product is their main product, and they are familiar with the distribution of suppliers. There are also many suppliers.

 

 

If you are an importer, import masks from China for the first time when you enter google or B2B website try to find some mask supplier or try to find a big chance for making money.be careful.

 

As of March 22, 2020, the price of ordinary civilian masks fell from 0.31USD / UNIT 7 days ago to the current 0.242USD / UNIT FOB price

 

As the inventory of domestic civilian protective masks is gradually sufficient, the price of civilian protective masks will continue to fall, and the vicious competition of Chinese mask suppliers will begin to appear, bringing a lot of quality risks to overseas mask importers.

 

Thousands of mask suppliers make you dazzled, prices are high and low, making you unable to make a choice in a short time.

 

 

The quality and materials of some cheap masks are just like garbage. Although the price is very low, no matter who uses it, it will not have any blocking effect on the coronavirus.

 

 

 

Use Bestforworld’s logistics services to ensure that your medical protection supplies are safe and reach your destination in a timely manner.  Stop using CIF high and opaque shipping costs.

 

 

BW suggestions:

 

Query customs data to see does your country have a relatively large and medium importer of medical supplies and which Chinese supplier they used. You can try to talk with these suppliers, ave you time.

We recommend working with medium and large Chinese mask suppliers because their products are more guaranteed and may be slightly more expensive, and delivery time cannot be prioritized.

 

The reason is the disinfection of medical masks. The sterilization time is at least 7 days instead of 7 seconds. Put a normal mask into a medical mask packaging bag.

 

And the Chinese government still strictly controls the circulation of medical surgical masks.

If you just want to get masks from China quickly and make a profit, I think maybe there are only many small factories that can meet the order of thousands or tens of thousands, and they can guarantee that under the current situation that disposable medical masks are still lacking, There are even many factories that can guarantee the production capacity of hundreds of thousands of disposable medical masks a day. It is really questionable because once these masks are replaced by medical masks, these masks will give those medical workers, Health care workers in close contact with coronavirus patients pose a huge risk of injury and infection.

At this time, morality and conscience should come first, As a businessman, you still have to maintain the most basic sense of responsibility.

 

If you have very rich import experience, from overseas, or from China, I believe that you can filter and compare suppliers by a few days, and evaluation by quotation, supplier analysis, email, chat. You will know which guy is the right choice.

 

If you have very little experience in the supply chain, but in your country, you have the capital and sales. We suggest that you can use Chinese trading companies and companies like BW, traders in China, middlemen to help you souring such products. save your time and energy.

 

 

 

 

Risks of importing masks from China:

 

1 The first risk is the risk of quality. At present, the quality of masks produced by Chinese mask suppliers has various grades.

Regardless of disposable medical masks or N95 masks, the price of a good quality mask is two or three times that of a poor quality mask.

 

Of course, you can choose to let trading companies and regular trading companies help you to purchase. They are responsible for screening, quality control, and reducing huge risks in whole supply chain.

 

Of course, you can also purchase directly from Chinese mask exporters.

 

 

 

Use Bestforworld’s logistics services to ensure that your medical protection supplies are safe and reach your destination in a timely manner.  Stop using CIF high and opaque shipping costs.

 

 

 

2 At present, many large-scale mask manufacturers are required to pay the full payment before placing an order.

 

This is a huge pressure and risk for the funds of overseas sellers and importers.

 

 

3 The risk of mask inventory. At present, many large and medium-sized mask exporters in China have a minimum order of 300,000 to 500,000. If you purchase nearly 1 million masks, do you have the ability in a short time to sell them out? worth considering

 

 

4 The risk of the delivery time of the masks, the current special epidemic situation, the raw materials of the masks, and the workers in the factories are in short supply. If a factory gives you a 100% guaranteed delivery time, please be careful.

 

5 The biggest risk is the supplier’s fake masks. Many Chinese masks suppliers ship protective masks to customers as medical masks, but earn more profit,We recommend customers with mask orders over millions and millions can contact BW for quality control:

There are two ways:

 

1 Find an import agent in China. As an intermediary, the overseas representative of the import agent in China signs the order contract with the factory. The contract can require any quality details of the product, especially when it comes to counterfeit masks. You can ask your Chinese agent to sue the Chinese mask supplier

In this way, the quality awareness of the supplier is enhanced, and the supplier is aware of the importance of quality.

 

2 Let the Chinese agent carry out daily disinfection, sterilization supervision during production, and station in the factory. Control quality at all times.

Of course, due to the current epidemic situation, many suppliers may not agree, but for importers of large orders, we recommend these suggestions. If you want to know more, you can send an email to learn about this agency service of BW. Better control the quality of your imported masks from China and keep your good reputation in the market.

 

 

 

The logistics solutions for importing and shipping masks from China :

 

There are many importers inquiring about how to choose a logistics solution. Should I choose to transport by sea or by air? In general, our recommendation is definitely to choose air. No matter using it for the government, or just selling for profit. we believe that you should receive the masks very fast.

 

Of course, for example, countries around China, such as imported masks from China to South Korea, Japan, and Thailand, Vietnam, Cambodia, Singapore, Myanmar, Laos, Malaysia, the Philippines, and other Southeast Asian countries, in fact, shipping by sea is still a good choice, the general voyage is only 6 -15 days or so, but shipping cost will save a lot compared to shipping the mask by air. If you want to import Chinese masks to Europe, North America, Australia, Africa, the Middle East, please choose air freight.

 

Of course, due to the outbreak, global airlines have canceled a large number of flights to and from mainland China, so the price of air freight has increased significantly, and aircraft cargo spaces are very tight, and they need to be reserved at least 7 days in advance. The international air transport market under the epidemic situation is also unknown.

 

Click  link below you will know :

 

Full details about Ship Masks And Medical Supplies From China,CE/FDA Certifications Guide, Customs Regulations, 75%Alcoholic Hand Sanitizer Cargo Clarification, Fast Delivery

 

 

 

Import and ship COVID-19 test kit, medical masks, medical protective clothing, ventilator, infrared thermometer,protective gloves, goggles from China.

One-stop guide&unserstanding, update 2020, All you need to know!(All legal, with all types of supplier resources attached!)

 

 

Below introducing the standards of import masks in several major countries and regions, and the basic customs clearance documents required for import clearance:

 

 

HS code of Coronavirus Outbreak Materials and Commodities Imported from China:

 

 

Mask: 6307900000

Rubber gloves: 4015190000

Protective clothing: 6210103000

Goggles: 9004909000

Disinfectant: 3808940090

Hand Sanitizer: 3401300000

Thermometer: 9025199090

Cotton swabs / swabs / cottons: 5601210000

 

 

Use Bestforworld’s logistics services to ensure that your medical protection supplies are safe and reach your destination in a timely manner.  Stop using CIF high and opaque shipping costs.

 

 

 

Import masks from China to South Korea

 

 

Necessary information (qualification)

 

When shipping masks from China to South Korea, Needed documents are Bill of lading, packing list, invoice, Korean importer’s business license, Korean consignee need to go to Korea Pharmaceutical Traders Association. File the import qualification website in advance: www.kpta.or.kr.

 

The company’s own use or as a gift. It can be imported by itself without the relevant qualifications.

 

Mask requirements

Masks also need to have a detailed country of origin label. If they are made in China, they must have labels: Made in China, manufacturer information, shelf life, and ingredient content instructions, manufacturing process. These documents have to been completed. After the goods arrive in South Korea, they will be sent to the laboratory for precise supervision and testing. After passing the testing, they can enter the Korean market for sale.

 

 

 

Import masks from China to Japan

 

 

Necessary information (qualification)

When shipping masks from China to Japan, Needed documents are Bill of lading, packing list, invoice, MDA-registered medical device companies exporting to Japan wishing to place their products on the Japanese market must meet the Japanese Pharmaceutical and Medical Device Act (PMD Act). Under the requirements of the PMD Act, the TOROKU registration system requires foreign manufacturers to register with PMDA Business information.

 

Mask requirements

The package is printed with 99% of the characters, which are medical masks that exceed the 95% domestic filtration efficiency (N95 mask) standard!

PFE: filtration efficiency of 0.1um particles and particles

BFE: bacteria filtration rate

VFE: virus filtration rate

カ ル ス カ ッ ト: virus blocking

 

  1. Medical protective masks: in accordance with China’s GB 19083-2010 mandatory standard, filtration efficiency ≥95% (tested with non-oily particles).
  2. N95 mask: American NIOSH certification, non-oily particulate matter filtration efficiency ≥95%.
  3. KN95 masks: Comply with China’s GB 2626 mandatory standard, non-oily particulate matter filtration efficiency ≥95%

 

 

Import masks from China to the EU

 

 

When shipping masks from China to EU, Needed documents are Necessary information (qualification)Bill of lading, packing list, invoice

 

Mask requirements

In the EU, masks are PPE personal protective equipment, “health-endangering substances and mixtures”. From 2019, the new EU regulation PPE Regulation (EU) 2016/425 will be enforced. All masks exported to the EU must obtain CE certification under the requirements of the new regulations.

 

CE certification is a compulsory product safety certification system implemented by the European Union to protect the lives and property of people in EU countries.

 

 

Import masks from China to the U.S.

 

Necessary information (qualification)

When shipping masks from China to the US, Needed documents are Bill of lading, packing list, invoice

 

If masks imported from the United States need to be sold, they must obtain FDA certification before they can be sold in the United States domestic market. For self-use and gifted masks, when importing US selling it is best for American importers to ask the US customs whether they also need FDA certification when purchasing Chinese masks and also pick the suppliers that have passed FDA certification for import to US market.

 

Mask requirements

According to HHS regulations, NIOSH classifies its certified anti-particulate masks into 9 categories. The specific certification is operated by the NPPTL laboratory under NIOSH.

 

In the United States, masks can be classified into three grades-N, R, P according to the minimum filtering efficiency of the filter material.

 

N-type masks can only filter non-oily particles, such as: dust, acid mist, paint mist, microorganisms, etc. Most of the suspended particles in air pollution are non-oily.

 

R masks are only suitable for filtering oily particles and non-oily particles, but when used for oily particles, the use time must not exceed 8 hours.

 

Type P masks can filter both non-oily particles and oily particles. Oily particles such as oil fume, oil mist, etc.

 

According to the different filtration efficiency, there are differences of 90, 95, 100, which means that the minimum filtration efficiency is 90%, 95%, 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 an “N95 mask”.

 

 

 

Import masks from China to Australia

 

 

Necessary information (qualification)

 

When shipping masks from China to Australia, Needed documents are Bill of lading, packing list, invoice

 

Mask requirements

AS / NZS 1716: 2012 is the standard for respiratory protective devices in Australia and New Zealand. Related product manufacturing processes and tests must comply with this specification.

 

This standard specifies the procedures and materials that must be used in the manufacture of particle respirators, as well as certain test and performance results to ensure their safe use.

 

 

Personal mail

 

  1. Since each country has different requirements for importing masks, it is recommended that you consult your local international freight forwarder or receiver before exporting to avoid the problem of masks detained or returned.

 

  1. The import and express delivery of self-use masks must be in a reasonable range. If the number is large, it may be seized by foreign customs.

 

  1. At present, international shipping and air transportation have not been fully restored, and transportation time is relatively long. It is recommended to pay attention to the number update after delivery and wait patiently. As long as there are no violations, they will not be seized or returned.

 

 

 

 

 

 

Comparison of quality and safety standards of protective masks in various countries

 

   Non- medical mask standard comparison

 

 

index country First class Second level Level 3 standard
 

 

Particulate filtration

EU ≥80% ≥94% ≥99% EN 149: 2001 + A1 Respiratory protective devices . The particle filtering half masks . Requirements testing, marking
United States ≥95% ≥99% ≥99.97% 42 CFR Part 84 Approval of respiratory protection equipment
Japan ≥80% ≥95% ≥99.9% JIS T 8151: 2018 anti-particle respirator
 

Korea

≥80%

( Half face )

≥94%

( Half face )

≥99.5%

( Half face )

 

KS M 6673: 2008 Anti-particle respirator

≥80%

( Full face )

≥94%

( Full face )

≥99%

( Full face )

Australia ≥80% ≥94% ≥99.5% AS / NZ 1716: 2012 anti-particle respirators

Comparison of quality and safety standards of protective masks in various countries

 

   Medical mask standard comparison

 

 

index country First class Second level Level 3 standard
Particulate filtration United States ≥95% ≥98% ≥98% ASTM F2100-2019 Standard Specification for Performance of Materials for Medical Masks
Japan ≥95% ≥98% ≥98% ASTM F2100-19 Technical Specification for Medical Mask Materials
 

Bacterial filtration efficiency

EU ≥95% ≥98% ≥98% EN 14683-2019 Medical masks . Requirements and test methods

Law Key performance indicators

United States ≥95% ≥98% ≥98% ASTM F2100-2019 Standard Specification for Performance of Materials for Medical Masks
Japan ≥95% ≥98% ≥98% ASTM F2100-19 Technical Specification for Medical Mask Materials
Australia ≥95% ≥98% ≥98% AS 4381: 2015 disposable medical masks
Synthetic blood penetration

resistance

( Mm Hg )

Japan ≥80 ≥120 ≥120 ASTM F2100-19 Technical Specification for Medical Mask Materials
Australia ≥80 ≥120 ≥160 AS 4381: 2015 disposable medical masks
Resistant to liquid splashes EU no request no request ≥120 EN 14683-2019 surgical masks . Requirements and test methods France Key Performance Indicators

 

 


 

The latest update combines the latest regulations of the Chinese government and the Chinese customs regarding the export of masks. The latest policy on March 31, 2020, how to distinguish between medical and non-medical masks, imported from China. Many importers do not know how to tell whether their imported masks are medical or not. In fact, 70% of the masks currently exported are non-medical masks.

 

Recently, as a large number of masks exported from China have been detained by the Chinese customs due to customs clearance issues, and the Chinese government’s short-term and rapid policy adjustments have caused many Chinese mask exporters and overseas mask importers to be very confused.

 

Mistakes in China’s export of non-medical masks are sometimes regarded as medical. On March 31, the Ministry of Commerce, together with the General Administration of Customs and the Food and Drug Administration, issued the Announcement on the Orderly Development of Export of Medical Materials (No. 5 of 2020), requiring that export of medical masks and other 5 types of products must be obtained Qualifications meet the quality standards of the importing country (region).

So, how to distinguish medical and non-medical masks imported from China quickly and accurately?

 

1 Basic classification and subdivision of imported masks from China

 

Masks can be divided into two categories: medical / non-medical. Medical masks are mainly used for medical protection, which can be subdivided into three categories: medical protection, medical surgery, and disposable medical; non-medical masks are also called personal protective masks, which can be subdivided into anti-particles and Two kinds of daily protection. Masks for different purposes have different technical requirements and different scopes of application.

 

 

2 Use appearance and packaging information to distinguish medical / non-medical masks

 

Distinguish by mask structure

 

 

Resolved by the filter valve. Masks with filter valves are generally not medical masks. For example, Article 4.3 of the Chinese Medical Protective Mask Standard GB 19803-2010 clearly states that “masks should not have an exhalation valve”. This can prevent droplets, microorganisms, etc. from exhaling through the exhalation valve, thereby harming others. Civil masks are allowed to have an exhalation valve. The exhalation valve can reduce the exhalation resistance, which is beneficial for the operator to work for a long time.

 

Identify by the information on the outer packaging

 

The minimum unit package of mask products sold through formal channels should have information such as the name of the product, the standards implemented and the level of protection. The information expressed by these businesses can be used as a distinguishing point. For example, if the product name contains “Medical” or “surgical” and “Medical” in English, it can generally be regarded as a medical mask.

 

 

3 National applicable standards distinguish medical / non-medical masks

 

Different standards and certification requirements apply to medical masks in different countries / regions. Enterprises and individuals can be distinguished according to the country / region in which the product is imported and according to the applicable standards of the product. Obtain test report or certificate.

 

 

Import masks from China to the United States

 

Medical masks are medical devices in the United States, and are subject to the “Standard Specification for the Performance of Medical Mask Materials” (ASTM F2100). They are managed by the US Food and Drug Administration (FDA) and must be registered through the 501K or other channels recently announced by the FDA to obtain factory registration Medical devices are listed in the United States after being listed. Therefore, the mask packaging exported to the United States or the test report or certificate that contains the above content can be judged as a medical mask.

 

Non-medical masks exported to the United States are outside the scope of Announcement No. 5 of 2020, but companies should note that Chinese mask products need to be registered by the NIOSH before they can be listed in the United States.

 

Import masks from China to the EU

 

The European Union medical / non-medical masks are required to bear the CE mark, but the applicable standards are different.

 

Medical masks belong to Class I devices in the European Union, which are divided into Class I non-sterile and sterile. They need to be affixed with CE in accordance with the EU Medical Device Directive 93/42 / EEC (MDD) or the EU Medical Device Regulations EU2017 / 745 (MDR) The mark, the corresponding standard is EN14683, and the mask packaging or test report or certificate exported to the EU contains the above-mentioned contents, and it can be judged as a medical mask.

 

It should be noted that according to the aseptic / non-sterile state of the mask, the EU adopts different conformity assessment methods. Non-sterile medical mask companies only need to make a CE self-conformity declaration, and do not need to pass the certification of the notified body. After preparing the relevant documents and test reports, you can complete the declaration of conformity yourself. Sterile medical masks must also be CE certified by an authorized notified body.

 

Non-medical masks exported to the EU are not medical devices, but they must meet the requirements of the EU Personal Protective Equipment Regulations EU2016 / 425 (PPE). CE certification and certificates are issued by authorized notified bodies. The corresponding standard is EN149.

 

 

Export to other countries and regions

 

Mask products exported to other countries and regions can be judged by referring to the Chinese standard test certificate and registration information provided by them. There are three Chinese medical mask standards, GB 19083-2010, YY 0469-2011, YY / T 0969-2013, use The masks produced by these three standards can be judged as medical masks.

 

 

4 Differentiate through government registration control information

 

Since medical masks are registered or controlled according to medical devices in most countries or regions, consumers can further distinguish through relevant registration control information. The following is an example of three countries and regions in China, the United States, and Europe.

 

Chinese medical mask registration information query

 

Medical masks belong to the second category of medical devices in China, and are registered and managed by the provincial drug regulatory department at the provincial level. You can query medical device access numbers through medical device query. The link is:

 

http://www.nmpa.gov.cn/WS04/CL2590/

 

 

American medical mask registration information query

 

Mask products that have been approved by the US FDA can be inquired through the official website to check the registration certificate number. The link is:

 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

 

In addition, according to the latest FDA policy, it is currently a mask that recognizes Chinese standards when certain conditions are met. The links to its authorized companies are:

 

https://www.fda.gov/media/136663/download

 

European Union medical mask registration information query

 

Medical masks exported to the EU can be queried through authorized notifying agencies. Among them, the address of the notifying agencies authorized by the EU Medical Device Directive 93/42 / EEC (MDD) is:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13

 

The enquiry address of the notified body authorized by the EU Medical Device Regulations EU 2017/745 (MDR) is:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

 

 


 

Here is a summary of the most questions we received from domestic mask suppliers and exporters this month

 

 

Q

Can China’s masks and other epidemic materials be exported now?

 

BW replied: outbreaks of non-medical devices managed by ordinary masks and other materials have no regulatory conditions, and companies with import and export rights can export directly. Certificate-related masks and other epidemic materials require three product certificates (1. The scope of the business license (including medical device business license, 2. Filing certificate or registration certificate, 3. Manufacturer test report)), and then the company has the right to import and export, And then can allow export.

 

 

 

Q

What qualifications are required for enterprises exporting outbreak materials?

 

BW replied: In summary, if the product is not certificate-related, it can be exported as long as it has the right to import and export. If it is a certificate-related product, four qualifications are required: import and export rights, three certificates of the product (1. The scope of the business license (including medical device business license, 2. Filing certificate or registration certificate, 3. Manufacturer test report)) Qualification requirements.

 

If an enterprise wants to give away or purchase instead of an overseas affiliated company, it needs a description of the situation, and the certificate-related products need to provide three certificates Before they can be exported.

 

 

 

Q

I want to export to Japan and Korea at the same time, do I have to meet the standards of their countries? What are the standards?

 

BW replied: Yes, it must meet the standards of other countries, otherwise it is impossible to enter.

Exporting to Japan is subject to the requirements of the PMD Act. The TOROKU registration system requires foreign manufacturers to register the manufacturer’s information with PMDA.

When exporting to Korea, the country of origin must be marked, and KF certification is required.

Masks exported to the United States must have FDA certification.

Masks exported to Europe must have CE certification.

 

 

 

Q

Now our company wants to export a batch of license-related masks, but it has no export qualifications. I want to ask if I can still export?

 

BW replied: if it is a factory with three certificates, it can be exported through foreign trade agents. If there are no three certificates, it cannot be exported.

 

 

 

Q

What qualifications and certificates are required for the export of ordinary masks and medical masks?

 

BW replied: General medicals masks, refer to use. The FDA’s management is based on product quality and standards. Masks of Class II and Class III medical devices require a filing certificate or registration certificate before they can be exported.

 

 

Q

Trading companies do not have medical equipment qualifications. Can they export masks? Manufacturers can provide three certificates, is there any problem with tax refund?

 

BW replied: Yes, it is completely exportable for manufacturers to provide three certificates. Of course, the business scope of foreign trade companies preferably includes content such as labor protection supplies. In this way, export tax rebates are safer.

 

 

 

Q

I want to personally deliver 200 masks to the United States?

 

BW replied: personal mail is currently not prohibited from exporting. Generally, express to 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 US FDA certification, some DHL simply refused to accept it, and some people reported that FEDEX refused to accept it. Then you can try it at the post office, or call each courier company before calling. However, the information we have so far is that masks do not have US FDA certification, and US Customs will refuse entry.

 

 

 

Q

We produce meltblown cloth. Would you like to ask for a medical device certificate for the export of meltblown cloth?

 

BW answer: Meltblown cloth is not a medical device, so no medical device certification is needed.

Regarding whether it is a medical device, you can go to the official website of the China State Food and Drug Administration to check

 

Website: http://samr.cfda.gov.cn/WS01/CL1026/

 

 

 

Q

What certification do I need to apply for if masks are to be exported to Iran?

 

BW replied: Exporting to Iran is still relatively complicated, and it is necessary to apply for COI certification in Iran. which is the relevant inspection required by Iran for mandatory shipping. At present, Iran’s N95 masks and ordinary three-layer masks, respirators, surgical gowns, nucleic acid detection kits, personal protective equipment, protective masks, and protective clothing are in short supply. To encourage imports, Iran ’s “Economy Online” reported on February 26 that the import tariff on masks in the Iranian market has been reduced from 55% to 5%.

 

 

 

Q

I just consulted the customs about the supervision of the export of masks. The other side responded that the customs of the export of masks are not monitored. Please consult the Food and Drug Administration for requirements. What does it mean?

 

BW answered: Customs has no supervision conditions, all customs said that they would not be supervised. But it was said that the FDA has a requirement, so the requirement of the FDA is to have a certificate-related product. Therefore, it can be understood that compliance export and license-related need to follow the requirements of the Food and Drug Administration, but there is no ban on export!

 


 

Do all masks imported from China require Commodity inspection when doing the customs clearance?

 

Medical masks exported from China are legally inspected products. Do I need to apply for an electronic fund account before customs declaration?

 

When exporting medical masks from China, what accompanying documents should be submitted for customs declaration?

 

Are non-medical masks need do the legal export inspection commodity or not? What are the special requirements for China customs declaration?

 

Masks imported from China are medical masks, but not for medical institutions, only for enterprise employees or consumers. Can they be declared as “non-medical”?

 

 

The above are our most common questions from March 30, 2020 to April 14, 2020. Mask suppliers from China and importers of masks from overseas, the latest update is April 14, 2020 (from BW customs department summary)

 

At the press conference of the Joint Defense and Joint Control Mechanism of the State Council of China held on April 13, Jin Hai, Director of the General Operations Department of the General Administration of Customs of China, and relevant heads of relevant departments on strengthening the prevention and control capabilities, new regulations on the export of medical materials, and how to strictly control medical materials New export policy.

 

The latest policy updates and interpretations of China Customs sea masks declaration and commodity inspection:

Mask export quick guide Q&A UPDATE 20204.15:

 

 

On April 10, the General Administration of Customs issued Announcement No. 53 of 2020, deciding to implement statutory export inspections on 11 categories of commodities such as medical masks, which immediately attracted the attention of exporters and importers of masks and other medical products from overseas.

 

On April-10 ,that one day,BW received more than 100 calls from China and around the world to consult the new regulations on the statutory inspection of mask declarations issued by China Customs. The BW customs declaration department summarized the hot issues related to the import of masks from China, and the most mentioned issues were shared with the world ’s importers of masks imported from China.

 

01 Are all exported masks need commodity inspection?

 

In order to strengthen the quality supervision of the export of medical materials, the General Administration of Customs issued Announcement No. 53 on April 10, 2020, to implement inspection of export commodities for medical masks and the following medical products.

1 Medical mask       

2Medical protective clothing   

3 Thermometer

4Ventilator

5Medical surgical cap

6Medical gloves

7Medical shoe cover

8Patient monitor

9Medical goggles

10 medical disinfection towels   

11Medical Disinfectant

 

Only medical grade products will be subject to commodity inspection, and non-medical products will not be subject to export commodity inspection.

 

02 The export of medical masks is need doing the commodity inspection. Do I need to apply for an electronic fund account before customs declaration?

 

Unlike other commodities subject to commodity inspection for export, the 11 types of medical materials newly added to the “Inspection of Legal Inspection” do not need to apply for an electronic fund account before exporting. They normally declare to the customs and do not need to provide an electronic account number during customs declaration. Of course, the origin inspection is not implemented and there is no need to apply for inspection at the origin.

 

 

03 When exporting medical masks, what accompanying documents should be submitted for customs declaration?

 

According to the “Catalogue of Medical Device Classification” (Announcement No. 104 of 2017 by the State Food and Drug Administration), medical masks are classified as Class II medical devices. During customs declaration, you must provide a medical device product registration certificate and export medical material declaration in accordance with the requirements of the “Announcement of the State Administration of Drug Administration of the Ministry of Commerce on Orderly Development of Export of Medical Materials” (No. 5 of 2020).

 

04Does non-medical masks belong to statutory inspection products for export? What are the special requirements during customs declaration?

 

Non-medical masks are not statutory export commodities for inspection. It is not necessary to provide a medical device product registration certificate and quality and safety commitment statement at the time of customs declaration, and the exporting enterprise should truthfully declare it.

 

05 The medical masks imported from China, but not for medical institutions, but for employees or consumers of enterprises. Can they be declared as “non-medical”?

 

No. When determining whether it is a medical mask, it is based on the attributes of the product itself, not the final use. Export companies should pay attention to avoid reporting errors because they do not understand the relevant requirements.

 

06 How do enterprises distinguish medical and non-medical masks when exporting?

 

Please refer to the content above this blog, already mentioned how to quickly and accurately distinguish between medical and non-medical masks

 

Non-medical masks

The KN90, KN95, KN100, KP90, KP95, KP100 and other series of masks that meet the requirements of the GB2626 standard are non-medical masks; masks with breathing valves are also non-medical masks. NIOSH certified N95 masks are not equal to medical protective masks.

 

07 What are the contents of medical and surgical masks imported from China? What does the so-called commodity inspection include?

 

This question is the most frequently asked question we have received from global buyers and Chinese mask factories, suppliers, and trading companies in the past 7 days. Many Chinese suppliers are very confused, and when the country introduced this policy, it started The specific content is also not very clear. BW currently publishes the latest and accurate information of the country. Regarding the medical masks, the complete content of how to inspect:

 

Article 44 of the Regulations on the Supervision and Administration of Medical Devices stipulates that “Enterprises exporting medical devices shall ensure that the medical devices they export meet the requirements of the importing country (region).

 

Article 6 of the “Commodity Inspection Law” stipulates that “import and export commodity inspections that must be carried out refer to conformity assessment activities that determine whether the import and export commodities listed in the catalog meet the mandatory requirements of national technical regulations. Conformity assessment procedures include: sampling and inspection And inspection; assessment, verification, and conformity assurance; registration, approval, and approval, and combinations of items.

 

Imported medical masks from China, the customs carried out on-site conformity assessment according to the requirements of the risk control directive:

 

  1. Verify that the actual goods are consistent with the medical device registration certificate;
  2. Check the product packaging, logo, product name, quantity and whether it is fraudulent or falsely reported;
  3. Evaluate the quality and safety commitment (conformity guarantee) or test report submitted by the enterprise;
  4. Inspection commodity appearance quality inspection;
  5. Sampling and sending to the laboratory to test the internal quality of the goods;

f ………….

 

08 What are the requirements for countries exporting bilateral medical agreements?

According to the bilateral agreement signed between the Chinese and foreign governments, the masks exported to the following 4 countries are required to apply for the implementation of pre-shipment inspection. If it meets the scope of pre-shipment inspection, it shall still implement the origin inspection + port supervision and installation in accordance with the previous export inspection commodity requirements, and the pre-shipment inspection certificate shall be issued by the customs.

 

Sierra Leone Each batch of trade commodities worth more than US $ 2000

 

Ethiopia Each batch of trade commodities worth more than US $ 2000

 

Iran Products listed in Chapters 25-29 and 31-97 of the “Catalogue of Entry-Exit Products for Inspection and Quarantine by Entry-Exit Inspection and Quarantine Institutions” with customs supervision conditions of B and inspection and quarantine category N.

 

Yemen Products in Chapters 25 to 29 and Chapters 31 to 97 of the International Convention on Harmonized Commodity Names and Coding Systems (HS Coding).

 

09  What kind of administrative punishment will the Chinese mask supplier or Chinese mask trading company face if they fail to declare the name of the customs declaration or export unqualified medical masks?

 

Those who falsely report medical materials as non-medical materials to evade inspection or who falsely report general commodities in Class C shipments as sample advertisements shall be punished severely according to law; those suspected of constituting crimes shall be transferred to local public security organs for criminal responsibility. We remind overseas importers to carry out legal declarations. Many importers have used illegal means to declare masks, which have been confiscated by the Chinese government. A large number of Chinese exporters of illegal masks have paid a large amount of fines.

 

Those who export counterfeit masks, fake or inferior masks, or impersonate qualified import and export commodities with unqualified import and export commodities, shall be ordered to stop exporting, confiscate their illegal income, and be fined not less than 50% and not more than three times the value of the goods; Investigate criminal responsibility according to law.


Starting from tomorrow, April 17, 2020, importing masks from China and wanting to use the “informal” way to ship overseas, the future road will become more and more “difficult”! It also means that DHL shipping masks from China will have more prohibitive and restrictive policies.

 

Just now, international express companies such as DHL have successively announced that they will no longer accept the export of medical masks of category C (KJ3) from China! You must take the normal D-type general trade declaration method, and the ant’s move is officially stopped! At present, many trial orders and sample orders are shipped through DHL shipping and imported masks from China.

 

After the outbreak of the epidemic in the world, because many medical supplies lack formal customs clearance, many importers of masks imported from China let Chinese mask suppliers use the C type (KJ3) declaration method instead of the formal D type. In the form of trade declarations, medical supplies are shipped abroad in multiple parcels of independent transportation. In the previous month, DHL ship a very large proportion of masks from China.

 

Although the General Administration of Customs of China issued the Announcement No. 53 of 2020 on April 10, the quality inspection of export commodities including 11 medical masks, medical protective clothing, infrared thermometers, etc., but many express delivery companies still accept Type C (KJ3) customs declaration method.

 

However, from tomorrow on April 17, 2020, international express delivery companies, including DHL, etc., have begun to notify customers not to accept Class C (kj3) export of medical materials. All companies must apply for Class D masks when applying for medical masks. Customs declarations in normal trading methods are required, and confirmation letters must be provided to prevent problems such as attribution of corporate responsibility and concealment of product names.

 

The latest weight and quantity of DHL import and ship masks from China:

For each DHL account, the import quantity from China cannot exceed 50KG (chargeable weight), and all those who use the company account and export masks must be officially declared by DHL.

 

At the same time, for prepaid accounts: the daily weight limit of a single account is 100KG (billed weight), cancel the world, and further notice, Europe and Australia, the single piece cannot exceed 30KG, the single shipment does not exceed 100kg, and the single piece in other countries does not exceed 70KG.

 

Recently, DHL shipments have caused frequent delivery problems, delays at transit airports, weight restrictions, quantity restrictions, and lack of flights. More and more complaints have been made by importers during the shipment of masks imported from China by DHL shipping.

 

What is Type C (kj3) customs declaration?

Class C (kj3) is a fast and convenient customs clearance method especially for express mail users. It is applicable to taxable samples and advertising products (except those that are subject to license management under laws and regulations), and is general air cargo. The special convenience that can not be enjoyed by transportation (formal customs declaration), the value of the goods needs to be less than 5000RMB, and there is no need to provide information such as customs declaration forms.

 

The D-type general trade declaration needs to provide a series of detailed information such as invoices, packing slips, customs declaration power of attorney, and medical device registration certificate.

 

Previously, many people would take the form of sub-wholesale goods, reduce the value of each batch of goods to less than 5,000 RMB use ants to move, ship with DHL shipping, and transport masks and other medical materials abroad. But now, this road has been blocked.

 

According to the regulations of China Customs on express shipments, express shipments are divided into the following four categories according to their value

 

Class A: refers to the absence of any commercial value documents;

Class B: refers to sample goods with a value below 50RMB;

Category C: Refers to sample goods with value above 50RMB and below 5000RMB;

Class D: refers to goods with a value of more than 5000RMB.

 

Here, BW reminds all importers who use DHL or UPS and other international couriers to import masks from China. China Customs has issued a large number of customs declaration prohibition and restriction policies. It is also hoped that Chinese mask exporters can improve the quality of medical supplies. .

 

 

How to safely and quickly import and ship mask from China:

 

1 Find legal, compliant, mask suppliers, who can provide all legal customs documents, many Chinese mask suppliers, even the basic customs information can not be provided,looking for Chinese mask suppliers that can provide legal certification, current Chinese mask suppliers, provide More than 80% of them are forged and counterfeit CE and FDA. If you want to quickly verify whether Chinese suppliers can provide a full set of legal declaration documents, as well as verify the certification required for overseas customs clearance, contact our consulting service.

 

2 Looking for professional and reliable Chinese freight forwarders. If you find a legal, compliant Chinese mask supplier is the first step when you import masks from China. Then find a professional and reliable Chinese freight forwarder. A Chinese shipping company who understands the rules and regulations of customs declaration, hand sanitizer and other anti-epidemic materials and customs declaration. Know how to verify all the customs declaration information of the supplier, and know how to verify the overseas customs clearance documents provided by the mask supplier. It seems very important. Because of the frequent updates and releases by the Chinese government and Chinese customs, and the latest customs declaration government, many Chinese mask suppliers and overseas importers get lost.


 

 

 

Use Bestforworld’s logistics services to ensure that your medical protection supplies are safe and reach your destination in a timely manner.  Stop using CIF high and opaque shipping costs.

 

 

Classification of common masks:

 

 

 

Common masks include the following: common cotton masks, Civil protective masks, disposable masks (such as medical-surgical masks), N95 masks.

 

Civil protective masks

The civilian protective masks are all flat. This mask is one level lower than the disposable medical mask protection. The structure is the same as that of the disposable medical mask, except that the melt-blown cloth used in the middle is a common melt-blown without electret treatment. Cloth, this kind of barrier effect is only droplets. If the fiber is made thinner, it will also have a short-term barrier effect against bacteria, but there is no adsorption force between charges, so it is not suitable for wearing in high-risk places such as hospitals. Of course, adequate protection for ordinary people living at home. Not recommended for use in enclosed and crowded locations.

 

Disposable masks (medical-surgical masks)

It can prevent respiratory tract infection to a certain extent and cannot prevent haze.

There are three layers of medical surgical masks, which are waterproof layer, filter layer and comfort layer from outside to inside. The comfort layer is a layer of non-woven fabric. When wearing, the white non-woven fabric faces inward, the blue waterproof layer faces outward, and the side with the metal sheet is facing up. Fit your nose and smooth your cheeks so that there is no gap between the mask and your face.

Please pay attention when purchasing, you should choose a mask on the outer package clearly marked “Medical-Surgical Mask”.

 

 

N95 mask

It can effectively prevent respiratory infections, can prevent haze.

The N95 mask is one of nine anti-particulate masks certified by NIOSH. “N” means unsuitable for oily particles (oil fume produced by cooking is oily particles, and droplets produced by people speaking or coughing are not oily); “95” means filtering under the detection conditions specified by the NIOSH standard The efficiency reaches 95%.

 

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 an “N95 mask”.

 

The biggest feature of the type mask is that it can prevent droplet infection caused by the patient’s body fluid or blood splash. The size of the droplets is 1 to 5 microns in diameter.

 

The U.S. Occupational Safety and Health Administration (OSHA) requires medical institutions that medical workers exposed to tuberculosis bacteria must wear masks higher than N95.

 

Compared with medical surgical masks, N95 masks are better closed. When choosing an N95 mask, try to choose an N95 mask without a breathing valve. Because the patient wears a mask with a breathing valve, it is equivalent to directly transmitting the germs to the surrounding people, without blocking the germs of the patients.

 

After reading this, we believe that everyone has an understanding of the difference between disposable medical masks and N95 masks.

 

N95 is not a brand, it is a mask model. N95 is based on the American standard, which divides professional protective masks into three types and nine types.

 

 

Ordinary cotton face mask

Its material may be cotton, gauze, wool, canvas, and velvet. Because the material itself is not dense enough, it cannot serve the purpose of preventing infection.

 

 

Must I wear an N95 mask to prevent this coronavirus?

Academician Zhong Nanshan, leader of the high-level expert group of the National Health and Medical Commission of China, said that if the body develops symptoms such as fever and cough, it is necessary to wear a mask, but for ordinary people, it is not necessary to wear an N95 mask. Because these viruses do not exist alone, they often reside in droplets. Ordinary surgical disposable masks can still block most viruses, and wearing masks is still useful.

 

In other words, for the purpose of self-protection and reducing the risk of respiratory infections, wearing surgical masks and N95 type masks can be used. If the current medical equipment is in short supply, we hope that the N95 mask with a tter protection level will be left to the hospital staff.

 

If you are going to the general open-air public place and do not contact the patient, you can choose to wear a medical-surgical disposable mask without excessive protection; but if you will contact patients with suspected respiratory infections, you should wear N95 masks.

 

 

When do I need to wear a mask?

You should wear a mask when you go to the hospital to see a patient or visit a patient, especially when you go to the hospital’s fever clinic or respiratory department;

 

In the season of a high incidence of respiratory infectious diseases, it is recommended to wear masks in supermarkets, shopping malls, theaters, and other crowded places

 

In order to prevent the disease from being transmitted to others, you should wear a mask in time when you have symptoms of respiratory diseases such as fever, cough and runny nose;

 

It is recommended to wear a mask when haze weather is outdoors.

 

 


 

 

How to put on, use, take off and dispose of a mask?

 

Before putting on a mask, clean hands with alcohol-based hand rub or soap and water.

 

Cover mouth and nose with mask and make sure there are no gaps between your face and the mask.

 

Avoid touching the mask while using it; if you do, clean your hands with alcohol-based hand rub or soap and water.

 

Replace the mask with a new one as soon as it is damp and do not re-use single-use masks.

 

To remove the mask: remove it from behind (do not touch the front of the mask); discard immediately in a closed bin; clean hands with alcohol-based hand rub or soap and water.

 

 


 

Summarize the most common Q & A, FAQs, and FAQs for the ship and import of masks, PPE, and medical supplies from China from March-1 to  May-1, mainly including the following aspects:

Updated on May 6, 2020, Beijing time

 

How does China Customs tighten the declaration of PPE, masks, and anti-epidemic supplies?

What are the provisions of the fifth announcement and the 12th announcement announced by the Chinese government? How to affect the normal customs declaration of goods?

Import from China, delivery masks, PPE, medical supplies, how to declare?

How to import PPE, masks, and medical materials from China to be truly safe? How to import is the safe way?

How to choose a legal, compliant, the Chinese government authorized PPE, mask medical supplies supplier?

How to reduce the risk of PPE, masks, medical supplies being seized and confiscated by China Customs?

How to find a professional freight forwarder to help me ship PPE, masks, and epidemic prevention materials from China?

What are the latest regulations, restrictions, and prohibitions for importing PPE from China and medical materials for masks?

What is the current situation of China Customs’ inspection of medical materials exports?

Why did my mask, PPE, and medical supplies from China delay?

Why does the Chinese government always amend the customs declaration regulations?

Should I import PPE or medical supplies from China?

Does the Chinese government restrict the export of masks, PPE, and medical supplies?

How to buy KN95 masks from China?

How to buy disposable masks and KN95 masks from China?

 

At present, China Customs strengthens the review of export declaration documents and on-site inspection to ensure the orderly export of medical materials, including:

 

  1. Implement 100% document review of the export of medical materials, including a comprehensive review of invoices, checklists, medical device product registration certificates, and companies’ declaration of quality standards submitted by the enterprise. The audit found and detained a batch of non-conforming quality Required medical supplies for export;

 

  1. Strengthen the inspection of the export of medical materials, and set the inspection focus by reviewing the internal and external packaging, color appearance, production date, shelf life, and certification of the goods to prevent the unqualified medical materials such as Sanwu products and pollution deterioration from confusing; In particular, there are better requirements for the content of the product manual. For the masks and the internal and external packaging of medical supplies, logo printing has introduced new regulations.

 

  1. Strengthen the review of brands of exported medical materials to prevent the occurrence of secondary risks such as infringement of intellectual property rights;
  2. Strengthen the audit of FDA, CE and other certification certificates to ensure that the certificates are accurate and meet the product’s declaration standards;

 

 

How to identify: counterfeit and shoddy anti-epidemic materials, masks, PPE

For example, during the inspection process, three non-products were found (no manufacturer, no implementation standard, and no expiration date). These are obviously unqualified epidemic prevention materials and cannot be exported.

 

If the products exported have CE, FDA, NIOSH, are they considered as medical?

The certification mark is not the only basis for judging medical treatment, mainly from the name of the package (MEDICAL, SURGICAL is medical), and the implementation standard.

 

For China, it is a non-medical personal protective mask. Is it necessary to apply for CE certification if it is exported to the EU? Instead of a sterile medical mask, you only need to declare yourself to enter the EU?

Personal protective masks are not medical devices, but they must meet the requirements of the EU Personal Protective Equipment Regulations EU2016 / 425 (PPE). CE certification is issued and certificates are issued by authorized notified bodies. The corresponding standard is EN149. According to the standard, the masks are divided into three categories: FFP1 / FFP2 and FFP3. Non-sterile medical masks are low-risk medical devices in the EU medical device classification. Only entering the EU requires companies to make a declaration of conformity and complete the technical documents and products of the product Registration, relevant conformity assessment is performed by the enterprise itself.

 

Does KJ3 export medical materials also in accordance with the requirements of China Customs Announcement No. 5?

Yes. The requirements of Bulletin 5 currently do not distinguish the nature of trade, and general trade, donated materials, and other import and export are all provided free of charge.

 

The certificate required by China Customs Announcement No. 5 should be the certificate submitted by the export trading company to the manufacturer? Because of the second-class medical device, the trading company does not need to register a license, it seems that it only needs to be filed, right?

Announcement No. 5 clarified that from April 1, companies exporting new coronavirus detection reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers must provide written or electronic statements when they declare to the customs, promising that the exported products have been made in China. The medical device product registration certificate complies with the quality standards of the importing country (region). The customs shall check and release the medical device product registration certificate approved by the drug supervision and administration department. This medical device registration certificate refers to the “Medical Device Product Registration Certificate” of the manufacturing enterprise. At present, customs have no special qualification requirements for trading companies.

 

Regarding the export of medical materials or Class I, II, and III medical devices by a trading agency do the customs need to verify any medical scope, qualifications, and licenses of the trading company?

Trade agency companies need to have the right to import and export operations and the scope of related goods import and export business, without the need for medical device qualification license.

 

What are the testing standards for masks and PPE?

Masks are divided into medical / non-medical types. Medical masks are divided into medical protection, medical surgery, disposable medical; non-medical masks are also called personal protective masks, which are divided into two types: anti-particulate and daily protective masks.

 

The testing standards of Chinese masks are as follows:

Medical protective mask: GB 19083-2010

Medical-surgical mask: YY 0469-2011

Medical disposable masks: YY / T 0969-2013

Industrial anti-particulate masks (such as KN95 masks): GB 2626-2006

Daily protective mask: GB / T 32610-2016

Ordinary mask: FZ / T 73049-2014Q

 

Is the filing of the first type of medical device counted as civilian use?

The first type of medical device belongs to medical

 

How to distinguish between medical and non-medical?

Judge whether it is medical or non-medical from product packaging and implementation standards.

 

Take a mask as an example:

  1. Distinguish from appearance and packaging information: masks with filter valves are generally not medical masks. If there is “medical” or “surgical” ‘Medical “on the outer packaging, it can be judged as a medical mask.

 

  1. Distinction by applicable standards: Medical masks apply different standards and certification requirements in different countries/regions, and can be distinguished according to the countries / regions where the products are imported and the applicable standards of the products. Product applicable standards and certification information can be provided from the product packaging or production Obtained the test report or certificate.

Standards of medical masks in three countries / regions: China, America, and Europe: KN / N / CE

  1. Distinguish through government registration and control information

 

United States: Mask products that have been approved by the United States FDA can be inquired through the official website to check the registration certificate number, the link is: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

 

In addition, according to the latest FDA policy, it is currently a mask that recognizes Chinese standards when certain conditions are met. The link to its authorized company is: https://www.fda.gov/media/136663/download

 

EU: Medical masks exported to the EU can be queried through authorized notified bodies. Among them, the notified address of the notified bodies authorized by the EU Medical Device Directive 93/42 / EEC (MDD) is: https://ec.europa.eu/growth/tools -databases / nando / index.cfm? fuseaction = directive.notifiedbody & dir_id = 13

 

The inquiry address of the notified body authorized by the EU Medical Device Regulation EU 2017/745 (MDR) is: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

 

We are an enterprise producing auto parts and have the right to import and export. Can we directly export anti-epidemic materials?

  1. Confirm whether the company’s business scope has relevant business licenses (such as import and export of goods, import and export of technology, import and export of agents).
  2. If it is produced by itself, the 5 types of materials involved in Announcement 5 and the medical materials in Announcement 53 need to have medical device qualifications. If you purchase from other manufacturers, you need to purchase from manufacturers with medical device qualifications

 

Is the mask machine a medical device? Does the export of civilian masks need to be restricted by the export qualification of medical devices?

The mask machine is not a medical device. Non-medical masks are not medical devices and do not need to be restricted by the export qualification of medical devices, but need to meet the relevant entry requirements of the importing country. For example, the European Union’s CE certification or approval certificate, personal protective masks must obtain US NIOSH testing registration, medical masks must obtain US FDA registration approval, and Japan needs to register with PMDA.

 

Is it necessary to submit domestic registration qualifications at the time of customs declaration if words such as medical are printed on the packaging?

Yes

 

In addition to requiring the factory to provide a medical device registration certificate for a Chinese trading company to export medical masks, does the trading company itself also need to provide a medical device registration certificate?

Trading companies do not need medical device-related qualifications.

 

When purchasing or inspecting goods from a Chinese trading company, what qualifications and materials should be paid attention to?

  1. Enterprise production license
  2. Product inspection report
  3. Medical device registration certificate or record certificate (not required for non-medical)
  4. Product manual (provided with the product), label (provided with the attached product)
  5. Product batch/number (outer packaging)
  6. Product quality and safety certificate or certificate of conformity (provided with the product, according to the smallest package)
  7. Product sample pictures and outer packaging pictures
  8. Certificate or other certification materials for foreign entry (such as CE certificate, etc.)

 

The Chinese trading company has the right to import and export and is ready to buy masks for export. The manufacturing company has a medical device registration certificate and meets foreign quality standards. What information does the trading company need to prepare?

Medical masks require the consignor to make a declaration of conformity for the export of medical materials and submit a medical device registration certificate from the manufacturer.

 

China uses the YY / T 0969-2003 standard CE certificate to use 149: 2001 + A1: 2009 Can it be considered a protective mask?

YY is a medical industry standard and a medical mask. The corresponding CE standard should be EN14683, so this CE certificate showing EN149 is invalid.

 

If the scope of the production license is the first type of medical device, is the product produced by this factory considered personal protection product or medical?

According to Article 5 of the “Regulations for the Supervision and Administration of Medical Devices”: International classification management of medical devices. The first category refers to medical devices that are adequate to ensure their safety and effectiveness through routine management. An enterprise with a Class 1 medical device license does not mean that the product produced must be a medical product. It depends on the standards for the production of the product and the registration information of the Food and Drug Administration where the specific product is located.

 

What kind of medical device is the Coronavirus Accounting Test Kit?

The new coronavirus kit, which is related to the detection of pathogenic pathogen antigens, antibodies, and nucleic acids, belongs to the third category of in vitro diagnostic reagents according to national regulations.

 

Should the materials donated by Chinese NGOs be donated through the Chinese Red Cross?

There is no mandatory requirement in this regard.

 

 

1) If foreign trade companies take orders, what materials do they need to provide if they export non-medical masks and protective clothing? If materials need to be provided, are these materials provided by the production plant?

2) Are personal protective masks and protective clothing non-medical standards?

3) Do non-medical masks and protective clothing exported to the United States require NOISH certification?

 

1) Non-medical ones can provide information according to ordinary goods.

 

2) Masks and protective clothing produced in accordance with non-medical standards are personal protective materials.

 

3) The export of personal protection and protective masks to the United States must obtain the US NIOSH test registration.

 

Because Chinese and foreign medical standards are different, especially masks, can we specifically summarize the question? At present, some domestic manufacturers of disposable medical masks (domestic standard YY / T0969-2013) for anti-epidemic materials have been approved in China. These manufacturers are all filing certificates. Can they be exported as protective (non-medical) masks?

Exports from China: Enterprises should truthfully declare that the domestic standard YY / T0969-2013 is medical masks, which should be declared in accordance with the requirements of medical masks.

Overseas imports: Must meet the requirements of the importing country/region and obtain the relevant certification approval of the importing country.

 

What materials are required for non-medical purposes?

According to the supervision conditions corresponding to the ordinary goods and commodity codes, the export is declared, but the relevant certification approval of the importing country is required.

 

Question about the name of the declaration: brand + specifications + disposable medical mask?

Yes. For the export declaration of masks and protective clothing, please fill in the brand, specification, model, and use in the commodity name column of the declaration form in accordance with the declaration requirements. If the actual attribute of the product meets the medical standard, it must be reported as “medical”. The declaration of medical materials export and the filling of other fields in the customs declaration form strictly comply with the requirements of the “People’s Republic of China Customs Customs Declaration Form for the Import and Export Goods Declaration” (General Administration of Customs Announcement No. 18 of 2019).

 

(When determining whether to use medical supplies, the actual attributes of the goods are used instead of the purpose of use, that is, even the medical masks used by individuals are declared “medical”.)

 

Does medical English packaging require medical treatment?

At present, many of the epidemic prevention materials approved by China are filed for medical surgery, because there are standards on the outer packaging. However, none of the companies that have filed for production currently have a registration certificate, that is to say, they cannot be exported?

 

The outer packaging is labeled Medical, and the implementation standard is that medical is medical supplies. The outer packaging and the implementation standard should be consistent to avoid penalties for failure to declare truthfully.

 

Medical manufacturers must have a medical device registration certificate.

 

What should be paid attention to when exporting civilian masks? Matters needing attention in the export declaration of civil masks?

For the export of civilian masks, the Chinese customs have no special qualification requirements for production and sales units and domestic shippers, except to meet domestic production and market circulation qualification requirements. Declaration specification: fill in according to the specification declaration requirements, and reflect “non-medical” in the declaration. In addition, it must comply with the regulations and requirements of the importing country.

 

What information do I need to provide for the export of protective clothing?

First of all, distinguish whether the protective clothing is medical or not. Non-medical services are carried out in accordance with the normal customs clearance requirements. The export of medical protective clothing needs to comply with the export legal inspection requirements of Announcement No. 5 and Announcement No. 53 of the General Administration of Customs.

 

 Can the epidemic prevention medical kit come out as a whole? (It contains masks, disinfectant, band-aid, iodophors, medicine box, disinfectant wipes, disposable gloves, disposable shoe covers, goggles, thermometer)

It does not comply with the definition of retail packaging in general rule 5 of classification. It is recommended to classify and declare separately.

 

The Chinese export company provides a declaration of conformity. What is the declaration? Is it the statement in Bulletin 5? But is n’t Announcement 5 only needed for medical use?

According to Announcement No. 5, from April 1 onwards, companies exporting coronavirus detection reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers must provide written or electronic declarations to the customs when they declare that they have obtained export products The medical device product registration certificate complies with the quality standards of the importing country (region).

 

The customs for non-medical epidemic prevention materials have no special requirements.

 

If civil use is out of the EU, should Chinese companies issue a declaration of conformity?

Not required for non-medical use.

In addition, the non-medical personal protective masks currently entering the EU belong to the category III serious protection risk, and CE certificates are required.

 

If we export protective materials to customers for factory employees to protect themselves, is it considered medical?

Determine medical or non-medical according to the actual attributes of the product, not according to the purpose of use. That is, even medical masks used by individuals are declared “medical”.

 

If a trading company exports, as long as the manufacturing enterprise has complete qualifications and meets the requirements of the importing country, can the trading company make a single declaration of export tax rebate?

A trading company may export its own goods by way of declaration. The entrusted export declaration form needs to reflect the production and consumption unit, which is subject to the requirements of the local customs.

However, the relevant qualification documents must be provided in accordance with the relevant customs requirements.

 

I would like to ask if there is 99% antibacterial (BEF99% PFE99% VFE99%) on the packaging of ordinary masks, but the use standard is GB / T32610-2016 non-medical standard. Is it still not a medical mask? Can it be exported as a common civilian mask?

Yes, GB / T32610-2016 is a non-medical mask.

 

Are export sales certificates and export records filed only when requested by the importing country?

The export of medical materials shall be provided with relevant export qualifications according to Announcement No. 5 and the General Administration of Customs Announcement No. 53 for export legal inspection, as well as the requirements of the importing country during customs clearance in the importing country.

 

Do domestic registered foundations donate medical supplies to foreign countries, must they pass the Red Cross? How to do it without passing the Red Cross?

Foreign donations may not be through charities, and other imports and exports may be declared free, but the relevant requirements remain unchanged.

Due to the recent policy changes, the answers to the above questions are for reference only, please refer to the local customs site requirements.

 

Do I need to apply for an export license for alcohol exports?

According to the content of product ingredients, etc., determine the commodity code and corresponding regulatory conditions to declare export. For unmodified ethanol with an alcohol concentration of 80% or more, the tax number 22071000 is related to the supervision of the G certificate, that is, “Export License for Dual-Use Items and Technologies (Targeted)”. Licenses issued when items and technologies are exported to specific countries (regions). Taking 2207100000 unmodified ethanol with an alcohol concentration of 80% or more as an example, the declaration elements: 0: brand type; 1: export benefit situation; 2: product name [Chinese and foreign name]; 3: processing method [unmodified, Modification]; 4: Alcohol concentration; 5: Brand [Chinese and foreign name]; 6: GTIN; 7: CAS; Regulatory conditions: ABG Inspection recommendation category: MR / NS

 

Now, do you need to print the factory name, address, phone number, and then attach a certificate of certification and instructions on the export of civilian disposable flat masks on the inner box and outer box, and then attach the certificate, instruction manual, otherwise it will be regarded as three products?

Yes. All should be qualified products.

 

Can medical devices import into the country during the strained period of the previous national defense epidemic be exported abroad?

For example, a ventilator (with medical equipment import registration certificate), what are the requirements of domestic customs when exporting?

It is recommended to deal with the return method.

 

Is commodity inspection a production enterprise or a trading enterprise to conduct commodity inspection?

For goods subject to export legal inspection, the manufacturer or foreign trade company may apply for inspection at the customs where the manufacturer is located and handle the electronic fund account. (Reminder: For the 11 types of export legally inspected medical materials listed in Announcement No.53, declare through a single window. Unlike other export legally inspected commodities, the newly added legally inspected export medical materials do not need to carry out origin inspection and do not Export electronic accounts.)

Legal basis: The consignor of export commodities under statutory inspection in accordance with Article 24 of the Import and Export Commodity Inspection Law and the Implementation Regulations of the Import and Export Commodity Inspection Law shall hold the contract within the place and time limit uniformly prescribed by the General Administration of Customs And other necessary documents and relevant approval documents to the entry-exit inspection and quarantine agency for inspection. Exported goods that are legally inspected are not allowed to be exported if they have not been inspected or have failed the inspection.

Export commodities should be inspected at the place where the commodities are produced. The General Administration of Customs may designate inspections at other locations according to the needs of facilitating foreign trade and the inspection of import and export commodities.

 

For the export of commodities subject to verification management, the consignor shall apply to the entry-exit inspection and quarantine agency for verification. The entry-exit inspection and quarantine agency shall carry out verification in accordance with the provisions of the General Administration of Customs.

 

Civil protective masks, non-medical, do you need a legal inspection?

No need.

 

If the company has only one type of medical product for record and does not have a registration certificate, can it be exported? Is it only necessary for the second type and third type of medical device registration certificate?

Yes, the filing of the implementation of a type of medical device is not a registration. Therefore, there is only a record certificate and no registration certificate.

According to Article 8 of the Regulations on the Supervision and Administration of Medical Devices, the first category of medical devices is subject to product record management, and the second and third categories of medical devices are subject to product registration management.

 

What certificates do we need to export to the United States?

Personal protective masks must obtain US NIOSH testing registration, and medical masks must obtain US FDA registration approval.

 

What is the difference between the application for sanitary quarantine approval of the export clearance requirements of coronavirus detection reagents and the declaration of export legal inspection goods?

There are two links. Sanitation and quarantine approval is a prerequisite for the declaration of reagents for legal inspection. For the export of testing reagents, you need to apply for health and quarantine approval first, and then go through export inspection and quarantine in a single window.

 

Do all the frontal temperature guns belong to medical supplies? Is it equally divided into medical and non-medical?

According to the “Catalogue of Medical Device Classification”, the frontal temperature gun belongs to the body temperature measuring equipment, and the management category is the second type of medical device. According to the “Measures for the Supervision and Management of Medical Device Operations”, the registration management of the second and third types of medical devices is required to apply for the “Medical Device Registration Certificate”.

 

I would like to ask when exporting disposable non-medical masks to Japan, must JHPIA provide them?

The current Japanese standards for non-medical masks are:

JIS T 8151: 2018 “dust mask”

Japan Hygienic Materials Industry Association JHPIA: “Voluntary Standards for Mask Display and Promotion”

Japan Hygienic Material Industry Association JHPIA: “Mask Hygiene Safety-Voluntary Hygiene Standard”

The export of disposable non-medical masks to Japan is not mandatory due to voluntary standards.

 

What are the specific requirements of the customs on the outer packaging and packaging of products such as masks? For example, large cartons are not approved, small packages are required, and they cannot be neutral packages. Can the requirements of customs for packaging be refined?

The packaging must meet the inspection and quarantine requirements for export packaging.

The following points should be noted for the export packaging of masks, for reference, the specific requirements shall prevail.

  1. The word FDA does not appear for civilian use (non-medical use). FDA is for medical use, and the Customs strictly investigates. Enterprises should declare truthfully.
  2. The information on the certificate is complete (product name, model specification, production batch, production date, quality assurance date, technical standard, material, manufacturer, etc.)
  3. Do not use simple bulk packaging, the smallest packaging can be retail packaging as standard, take standard color bags or standard carton.

 

Are melt-blown nonwovens controlled and not allowed to be exported, or conditionally exported? If there are export restrictions, how can I export them? If it is indeed forbidden, the foreign trade enterprise can cancel the plan to sign the contract early?

There are currently no special export controls.

 

If a foreign trade company exports medical device category 2 products, such as medical masks, does the foreign trade company need to go through the filing of category 2 medical device distribution, or is it a category 2 medical device distribution license?

The customs have no special requirements on the business scope of foreign trade enterprises.

For business scope requirements, it is recommended to consult the local market supervision bureau.

 

Do products sold domestically need to be inspected?

For domestic sales, it must meet domestic product standards.

Taking masks as an example, the domestic testing standards for masks are as follows:

Medical protective mask: GB 19083-2010

Medical-surgical mask: YY 0469-2011

Medical disposable masks: YY / T 0969-2013

Industrial anti-particulate masks (such as KN95 masks): GB 2626-2006

Daily protective mask: GB / T 32610-2016

Ordinary mask: FZ / T 73049-2014

 

The masks exported to Canada, the certification requirements originally learned are the same as the American standards?

But now it seems that there is no certification requirement, do the customs know the latest situation? Can it be exported directly?

Canadian medical device products are divided into 4 categories, one of which has the lowest risk and does not require MDL (device registration), only MDEL (manufacturer registration). Mask products are controlled as a class of medical device products in Canada.

 

Domestic manufacturing enterprises do not have civilian masks (labor protection products) in their business scope. Due to the needs of foreign guests, can the civil masks be combined with the goods produced by their own enterprises and exported to foreign guests in a container?

For the purpose of exporting customs masks for civil masks, fill in the purpose of the product name column, indicate non-medical, and declare as ordinary goods for export. At this stage, masks are commodities subject to strict investigation by the customs. It is recommended to separate development and transportation when conditions permit, to avoid affecting the customs clearance of other goods or overseas customs clearance.

 

Donation Category: Foundation donations, must the foreign recipient be a Red Cross or other government agency?

Can foreign NGOs also serve as recipients? If you donate, do you need the manufacturer or the foundation to prove the product quality?

Foreign recipients of donations can be social teams or individuals.

Announcement 5 and Announcement 53 currently do not distinguish the nature of trade. General trade donated materials, and other imports and exports are free of charge. Medical materials that fall within the scope of the announcement must provide medical device product registration/recording certificates and quality and safety commitment statement Procurement of medical material sales companies with equipment operation qualification, or purchase from manufacturers with medical equipment production qualification.

 

Excuse me, we are a foreign trade company. There are only two types of medical device licenses, but the factory has three types of medical device licenses. We want to export three types of medical devices. Can we be an export agent?

At present, China Customs has no business qualification requirements for foreign trade companies and can act as an agent for export.

For business scope requirements, it is recommended to consult the local market supervision bureau.

 

For N95 masks exported to the UK, how to judge whether the certification is standardized?

N95 is one of 9 types of particulate protective masks certified by the National Institute of Occupational Safety and Health, not a British certification standard.

 

GB KN90: filtration efficiency 90%; GB KN95: filtration efficiency 95%; GB KN100: filtration efficiency 99.97%.

American standard N90: filtration efficiency 90%; American standard N95: filtration efficiency 95%.

 

European standard FFP1: filtration efficiency ≥80%; European standard FFP2 filtration efficiency ≥94%; European standard FFP3: filtration efficiency ≥99%.

 

The filtration efficiency of national standard and American standard is only included for non-oily particulate matter, European standard oily particulate matter, and non-oily matter.

 

Aid materials declaration, export to non-EU countries, is CE unnecessary?

Regarding export declarations, Announcement 5 and Announcement 53 currently do not distinguish the nature of trade. General trad donated materials, and other import and export are free of charge, and medical materials must provide relevant qualification documents.

For overseas imports, the quality standards of the corresponding importing country (region) must be met. Different countries (regions) have different standards.

 

Exporting non-sterile medical masks to the EU, CE requirements are lower than personal protection, only need to declare?

First of all, the European Union standard for medical masks is EN14683, and the standard for personal protective equipment is EN 149. Medical masks are low-risk medical devices in EU medical devices, and personal protective masks are high-risk products in EU personal protective products; personal protective masks require a ce certificate from the EU Notified Body.

 

Non-sterile medical masks: enterprises only need to make CE self-conformity declaration, and do not need to pass the certification of the notified body. After preparing the relevant documents and test reports, you can complete the declaration of conformity yourself.

 

We export 6000 disposable medical masks, without CE in the outer packaging, can it be exported, can Belgium import non-sterile masks?

CE is an EU certification mark. Medical masks do not have a CE mark and cannot be exported. Please apply for certification before exporting.

 

Can isolation garments and protective clothing fall under one HS?

It is not possible to judge only from the product name. It is necessary to determine the product code according to the actual product attributes of the two. If the product attributes are the same, they can be classified into the same product code. If they are different, they are classified separately.

Except in special circumstances, most protective clothing should be classified into the following tax numbers according to the material: chemical fiber 6210030, rubber 40159010, plastic 39262090.

 

Is the isolation gown divided into medical and non-medical? What testing standards are required for medical?

Isolation gown is a broad concept. China’s protective clothing classification standard is the People’s Republic of China pharmaceutical industry-standard YY / T 1499-2016 “liquid barrier performance and classification of medical protective clothing”, which divides medical protective clothing into 4 levels, the higher the level, the better the protective performance.

 

Medical protective clothing belongs to the second-class medical devices, and it needs to be reviewed by the relevant standards of the second-class medical devices, and it is produced according to the requirements.

 

Is there any certificate required for non-medical goggles to be exported to India?

Non-medical goggles do not require relevant certificates.

The standard of medical goggles in India is: IS 5983-1980 “Eye Protectors” Eye-protectors

 

Disposable masks for civilian use, non-medical, do you need to be qualified by the Food and Drug Administration before they can come out?

No need.

 

Are there any requirements for the markings printed on the outer box of civilian materials and medical substances? Must be printed or can be posted? Is there information on both the manufacturer and the receiver?

The Customs strengthens the inspection of medical materials exports and sets the inspection focus by examining the internal and external packaging, color appearance, production date, shelf life, and certification of the goods to prevent unqualified medical materials such as San Wu and pollution deterioration.

 

Ask a question, the BFE of the mask is a medical standard, and the PFE is a civilian standard. Is the mask medical or civilian?

Judge whether it is medical or non-medical from product packaging and implementation standards.

Taking medical surgical masks as an example, industry standards YY 0469-2011 “Technical Requirements for Medical-Surgical Masks” stipulate, among which the standards for filtering:

 

Bacterial filtration efficiency (BFE): The bacterial filtration efficiency of the mask should be no less than 95%.

Particle filtration efficiency (PFE): The filtration efficiency of masks for non-oily particles should not be less than 30%.

 

What are the production and testing standards for meltblown fabrics?

China currently has recommended standards specifically for meltblown fabrics

 

FZ / T 64034-2014 “Spunbond / meltblown / spunbond (SMS) method nonwoven fabric”

 

GB / T 30923-2014 “Plastic Polypropylene (PP) Meltblown Special Material”

 

However, the general melt-blown cloth testing refers to GB 2626-2006 “Respiratory protective equipment-Self-priming filter anti-particulate respirator” (currently valid), the updated version of the standard GB 2626-2019 will be on July 1, 2020 Implementation.

 

Now, civil masks do n’t need commodity inspection, right? What is the inspection procedure for medical masks? What do factories and foreign trade companies do?

For the export of civilian masks, the Chinese customs has no special qualification requirements for production and sales units and domestic shippers, except to meet domestic production and market circulation qualification requirements. Declaration specification: fill in according to the specification declaration requirements, and reflect “non-medical” in the declaration.

 

Medical masks according to Announcement No. 53 are different from other commodities exported for legal inspection. Announcement No. 53 adds new legal inspections for exporting medical materials without the need to carry out origin inspections, and there is no need to export electronic accounts during customs declaration. The enterprise needs to fill in the purpose of declaration in the commodity name column of the declaration form and indicate the medical treatment. At the time of customs declaration, the medical device product registration/recording certificate and quality and safety commitment statement shall be provided.

 

If there is only one customs code, and both civil and medical use is this HS No. 63079000, is it necessary for legal inspection? And ordinary people in Europe and the United States do not wear masks, they must wear FDA / CE certification. Please help explain this?

The export of medical materials must meet both the requirements of Chinese standards and the standards of overseas importing countries (regions).

The standards of the importing country (region) are different for each country (region).

For example, the European Union’s CE certification or approval certificate, personal protective masks must obtain the US NIOSH testing registration, medical masks must obtain the US FDA registration license, and Japan needs to register with the PMDA.

 

Does the KN95 protective mask test only perform breathing resistance and filtration efficiency?

Industrial anti-particulate masks (such as KN95 masks): Technical standard GB 2626-2006, please check the specific standards.

 

How to export the KN95 mask to the EU?

KN95 is a non-medical mask, which is declared for export as normal goods, and reflects “non-medical” when declared.

It is required to apply for EU CE certification. A list of certification bodies with CE certification capabilities for masks and other anti-epidemic products in China is issued for certification.

 

Non-medical masks, printed with the FDA logo, can they be exported?

No. The US FDA is a medical mask, and the customs is currently rigorously investigating the goods printed with the FDA declaration as non-medical masks. Enterprises should declare truthfully.

 

What are the EU standards for personal protective masks?

EU registration/certification access requirements for personal protective masks: CE certification: (EU) 2016/425 (Personal Protective Products Regulations) 2020/403 / EU Conformity assessment and market surveillance procedures within the COVID-19 threat. Name of technical regulations and standards: EN 149-2001 + A1: 2009 “Respiratory protective device Particulate filter half-mask requirements, testing and marking”.

 

Are there any administrative penalties for failing to declare truthfully or exporting qualified medical masks by the Ministry of Export?

Those who falsely report medical materials as non-medical materials to evade inspection or who falsely report general commodities in Class C shipments as sample advertisements shall be punished severely according to law; those suspected of constituting crimes shall be transferred to local public security organs for criminal responsibility.

 

If the export is counterfeit, counterfeit goods or impersonation of unqualified import and export commodities as qualified import and export commodities, it shall be ordered to stop exporting, confiscate the illegal gains and impose a fine of not less than 50% and not more than three times the value of the goods; Beheld criminally responsible.

 

What is the list of Chinese mask manufacturers that have received the US FDA Emergency Use Authorization (EUA)?

As of April 17, 2020, there are a total of 81 companies. For details, please refer to the attachment, which is being continuously updated.

https://www.fda.gov/media/136663/download.

 

How to conduct an inspection of export commodities if medical disinfectants are dangerous chemicals?

If it belongs to dangerous chemicals, it shall carry out the origin inspection (if it belongs to dangerous goods, it shall also carry out the inspection and identification of dangerous goods packaging), and at the same time implement the port inspection according to the requirements of “Announcement 53”.

 

 

 

 

Import and ship COVID-19 test kit, medical masks, medical protective clothing, ventilator, infrared thermometer,protective gloves, goggles from China.

One-stop guide&unserstanding, update 2020, All you need to know!(All legal, with all types of supplier resources attached!)

 

 

 

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