The wonderful content of this blog includes the most common questions from Google, as well as the latest cases and lessons of BW currently shipping protective clothing from China, as well as the common problems of email consultation from many clients.

 

 

1 How to choose the right incoterm with your Chinese protective clothing supplier? FOB or CIF? EXW?

 

2 How to import a protective suit legally and compliantly from China?

 

3Why are some importers’ protective coveralls not exported from China successfully?

 

4 What documents should be provided by the protective clothing declaration in China?

 

5How to find a reliable supplier for protective clothing in China?

 

6How to ship protective clothing from China, by sea or by air?

 

7 What documents are required for customs clearance of protective clothing imported from China?

 

8How to import protective suit to the United States?

 

9How to choose protective clothing against coronavirus level?

 

10 National standards and grades for protective clothing.

 

 

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.

 

First, import protective clothing from China:

 

Export qualification of Chinese protective clothing suppliers:

The supplier qualifications and trader qualifications involved in the export of protective clothing required for the prevention and control of imported epidemics from China are basically the same. Medical-grade protective clothing is a second-class medical product:

 

Chinese protective clothing suppliers need:

The business license needs to have business scope for Class II medical products

Medical Device Production License

Test Report

 

Chinese protective clothing traders need:

Traders looking for Chinese protective clothing suppliers not only need to meet all of the above three conditions

 

At the same time traders need to have:

The business license needs to have business scope for Class II medical products

Recording of Class II Medical Device Operations

 

Protective clothing shipped from China:

 

The most common mistakes made by overseas importers are as follows when ship protective suit from China:

Don’t know how to choose and filter suppliers

 

Do n’t know how to make a declaration and choose incoterm.

 

1Choose a low-priced supplier. At present, Chinese materials are rising. If your Chinese protective clothing supplier’s price is lower than the market price, you must be careful, they may not have CE or FDA certification at all.

 

2 The wrong choice of the EXW term, because the EXW price looks like the unit price of protective clothing is very low, but they overlooked a question, how to complete China’s export declaration? Which company is looking up to declare to the Chinese customs?

 

Many experienced buyers who import from China believe that freight forwarding can look for a common exporter title. If your products are daily necessities, ordinary goods, it is OK. But in the past 2 weeks, masks and other protective supplies have been sent from China to the world. The Chinese government suffered a great deal of humiliation because of its poor quality. At present, the government adopts the strictest export policy for the protective coveralls ship from China.

 

If you ask the factory to purchase such items, if the factory has only manufacturing capabilities, although the certificate is complete, if you have paid the factory, your product still cannot be exported. You need to find a company who have class 2 medical product export permit ,You need to find a BW-like trading company with a medical device business scope. Not an ordinary export agency.

 

If you buy from the factory, the factory cannot provide the basic three documents, please stop talking immediately. Avoid wasting time and losing money.

 

If you ask a trading company to purchase, if the factory they use cannot provide three legal documents, your goods cannot be shipped from China.

 

If you want the purchasing the protective clothing from a Chinese trading company, if the factory selected by the trading company can provide three documents, and the trading company also has the export license of the second-class medical device, and complete the second-class medical device filing, congratulations, your product Can be shipped safely. Often Chinese protective clothing suppliers that meet this condition may not have the lowest price, but it takes money to complete all qualifications, certifications, and procedures.

 

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.

 

The following is a logistics solution and trade terms guide for shipping protection from China. The following content can answer some questions?

 

I should choose the CIF, EXW, or FOB  with the Chinese protective clothing supplier.

 

How to select, and find Chinese protective clothing suppliers?

 

What are the logistics risks of importing protective clothing from China?

 

Why is it so difficult for Chinese customs to import protective clothing from China? How to solve it?

 

I have made a payment to my Chinese protective clothing supplier, but the supplier cannot ship and cannot be legally exported?

 

1 To make FOB with suppliers, the suppliers must make their own company name and go through customs declaration procedures.

 

Because the supplier only needs to make the FOB  with you, all the risks caused by customs errors and the risk of confiscated goods are all within the scope of the supplier. If you do EXW or CIF, all the customs declaration points are shared by you or you alone bear, BW refuses to operate any EXW goods for Class II medical products. Don’t want to waste BW’s time and importer’s precious time.

 

2 When you make a payment from overseas to China supplier,the company name should be the same as the export declaration.

 

3 If you plan to purchase protective suits from China, identify the qualification of the factory in advance, and the qualification of the trading company, and the qualification of the factory purchased by the trading company, to avoid wasting valuable time.

 

4 Select BW as the freight forwarder, choose FOB’s logistics solution, better control the cost and safety of logistics, and enjoy the professionalism of BW’s anti-epidemic materials operations. By choosing BW as your freight forwarder from China and Asia shipping, your protective clothing import business will become easier.

 

 

 

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 protective clothing from China:

Commodity classification of Chinese protective clothing:

Except for special cases, most protective clothing imported from China should be classified under the following headings according to the material classification:

 

Medical protective clothing:

Manmade fiber  HS CODE 62101030

Rubber         HS CODE40159010

Plastic          HS CODE 39262090

 

The role of medical protective clothing:

Occupational protective clothing for medical personnel in medical institutions, to organize the virus from patients with coronavirus to spread to the medical personnel with air or liquid. Therefore, medical protective clothing is a second-class medical device. The export qualification of the trader lacks a document and cannot be exported.

 

Prohibition management of protective clothing imported from China:

At present, the Ministry of Commerce of the People’s Republic of China has not set trade control requirements for protective clothing, and the Chinese customs have no requirements for port inspection of protective documents for protective clothing.

 

Preferential Origin of Protective Clothing from China:

China has signed 17 free trade agreements with 25 countries or regions. Chinese-originated products, including epidemic prevention and control materials, can be exported to these countries and regions to obtain preferential tariff reductions based on preferential certificates of origin.

 

Taking the export of protective clothing to South Korea as an example, you can see that the tariff reduction is very large, so it is recommended to apply to the customs for a certificate of origin before export.

 

HS-CODE: 39262090 Preferential tax rate (applicable with the certificate of origin of China and South Korea) 2.6%

 

HS-CODE: 40159010 Preferential tax rate (applicable with the certificate of origin of China and South Korea) 3.2%

 

HS-CODE: 62101030 Preferential tax rate (applicable with the certificate of origin of China and South Korea) 5.2%

 

 

Entry requirements for countries importing protective clothing from China:

 

Import protective clothing from China to the United States

You must obtain FDA registration from the Food and Drug Administration in order to sell in the United States market.

 

US Protective Clothing Classification:

American medical protective clothing can be divided into two types of non-surgical protective clothing and surgical protective clothing. Non-surgical protective clothing is a Class I medical device, which is exempt from pre-market registration and can be directly registered with the institution. Surgical protective clothing is a Class II medical device and requires pre-market registration, that is, an application for FDA 510 (K) is required. Judgment basis for Class I and II medical protective clothing is shown in the table below.

 

Classification and judgment basis of protective clothing imported from China to medical protective clothing in the United States:

Judgment basis for non-surgical protective clothing:

  1. The label states “protective clothing” rather than “surgical clothing”;
  2. The label does not describe the product as a surgical gown;
  3. If the product has a statement regarding barrier protection, only the minimum or minimum level of barrier protection can be stated.

 

Judgment basis for protective clothing for surgery: [Requires pre-market registration, that is, application for 510 (K)]

  1. The label says “Protective clothing for surgery”;
  2. The label describes the product as protective clothing for surgery;
  3. The product claims a medium or high level of barrier protection, and / or the product claims that it can be used for aseptic processing.

 

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.

 

Lessons shared:

Many US importers believe that my Chinese protective clothing supplier has FDA certification, so I can import protective clothing from China to the United States. The US importer does not have an FDA ID, which makes it impossible to clear the goods in destination airport.

 

This is a major mistake made by currently importing protective clothing from China and 95% of US medical protective clothing importers. If you read this blog in advance, you should know exactly how to proceed to the next step. This article full of practical meaning is currently the only one and the latest one from Google. It is about purchasing protective clothing imported from China, customs declaration, sharing, and guidance.

 

BW has unreservedly shared with the world’s importers who want to purchase materials from China through case studies and lessons from sales in the forefront, and problems encountered in combination with customers, as well as back-office email integration.

 

Welcome to use BW logistics service when you purchase from China or other Asian countries.

We, not only ship from China. Our network cover whole Asian.

 

We will be your most trusted freight forwarder, a Chinese freight forwarder full of responsibility and professionalism.

 

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.

 

Some U.S. importers have an FDA ID,

 

However, if the protective clothing you purchased is a Class II surgical-grade, it needs 510K to allow entry into the US market. Many people ignore this factor.

In 2004, the FDA recognized the American National Standards Institute / American Medical Device Promotion Association standard ANSI / AAMI PB70 “Liquid Barrier Properties and Classification of Protective Clothing and Protective Cloth Used in Healthcare Facilities”. Companies applying for pre-market registration generally need to perform performance tests on protective clothing according to ANSI / AAMI PB70.

 

Import protective clothing from China to the EU

Must obtain EU CE certification and comply with technical regulations: (EU) 2016/425

On March 9, 2016, the European Union passed the Personal Protective Equipment (PPE) Regulation (EU) 2016/425, which revoked and replaced the PPE Directive 89/686 / EEC, which was officially implemented on April 21, 2018 and stated Products placed on the market after April 21, 2019 must meet all the requirements in (EU) 2016/425. This regulation covers the safety supervision of protective products such as protective clothing, respiratory protective equipment, gloves, etc. China’s deadline, China’s protective clothing export foreign trade enterprises and China’s protective clothing suppliers and factories must pay attention to.

 

According to Article 8 of Regulation (EU) 2016/425, protective clothing manufacturers exporting to the European Union need:

  • Ensure that its products meet the basic health and safety requirements listed in Annex II of the regulations;
  • Write the technical documents described in Annex III of the regulations;
  • conduct applicable compliance assessment procedures;
  • Writing a declaration of EU compliance;
  • CE marking on products according to regulations;
  • Mark the name, registered trade name or registered trademark, address of the manufacturer on the personal protective equipment;
  • Ensure that personal protective equipment is accompanied by a type, batch or serial number for easy identification;
  • Write instructions for use, provided with personal protective equipment. The instructions must include the name and address of the manufacturer and an Internet address to which you can connect to the EU Declaration of Conformity. If the EU Declaration of Conformity is attached with personal protective equipment, the instructions need not include an Internet address.

Within 10 years after the personal protective equipment is placed on the market, manufacturers must keep their technical documents and EU compliance statement.

 

Import protective clothing from China to Japan

If the product needs to be placed on the market, it must meet the Pharmaceutical and Medical Device Act (PMD Act) of Japan. Under the requirements of the PMD Act, the TOROKU registration system requires foreign manufacturers to register the manufacturer information with PMDA.

Japanese government agencies mainly formulate laws and regulations and conduct macro-management. Many specific business tasks are left to various industry associations. The main industry associations involved in protective clothing are the Japan Safety Equipment Association (JSAA) and the Japanese Protective Clothing Association (JPCA).

 

Japanese Safety Equipment Association (JSAA) website:

トップ

 

Japanese Protective Clothing Association (JPCA) website:

http://bougofuku.net/index.html

 

Japanese Medicines and Medical Devices Comprehensive Agency (PMDA) Website:

www.pmda.go.jp

 

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 protective clothing from China to South Korea

The regulatory thresholds for the admission of Korean medical devices are basically classified into categories I, II, III, and IV, and the license holders are Korean companies (License holders). Korean consignees must go to the Korea Pharmaceutical Traders Association. File the import qualification in advance.

Website www.kpta.or.kr.

 

On January 15, 2020, the Ministry of Labor of the People’s Republic of Korea Announcement No. 2020-35 “Notification of Safety Certification of Protective Equipment” gave performance standards and test methods for chemical substance protective clothing, dust masks, etc. According to the protective clothing performance standard content in the “Protection Equipment Safety Certification Notice”, protective clothing is divided into six categories:

Integrated protective clothing with breathing supply inside or outside

Integrated protective clothing with positive pressure breathing apparatus

Protective clothing against liquids

Anti-spray protective clothing

Dust Protective Clothing

Protective clothing against liquid splashes

 

Import protective clothing from China to Australia

Australian importers must be registered with the Australian TGA. TGA is the abbreviation of the Therapeutic Goods Administration, and its full name is the Therapeutic Goods Administration. Australian medical devices are classified into Class I, Is and Im, IIa, IIb, and III, which are exemptions, filing, and registration, respectively. Regardless of the type of medical device, it must be approved by the Australian government before it goes on sale. It meets the basic requirements for medical devices and is reviewed in accordance with the compliance review process.

 

Special reminder: Australia has reached a mutual recognition agreement with the European Union. This means that the conformity assessment certificate issued by TGA is also recognized by the European Union, and TGA also recognizes the European Union CE certification. Users who have obtained CE certification can submit CE certificates and related materials to obtain a TGA certificate.

 

If the product is registered or filed, the manufacturer’s replacement of the distributor has no effect on it. After the registration of foreign products is approved, regular registration is required once a year, indicating whether the product model, performance and quality have changed. TGA is solely responsible for evaluating the compliance of medical devices and charging a certain fee. The number of relevant fees can be found on TGA’s website.

 

 

Australian Therapeutic Commodities Authority (TGA) website:

www.tga.gov.au

 

The process of registration and certification of medical protective clothing exported to Japan, South Korea, and Australia is the same as that of medical masks. For the specific process, please refer to the registration process of imported masks from China:

 

A brief analysis of technical standards of protective clothing in various countries:

 

American Protective Clothing Standard

1.ANSI / AAMIPB70: 2003 (2012) “Liquid-repellent performance and classification of protective clothing and protective cloth used in health care facilities”

2.ASTMF1670-2017 “Test method for protective clothing to prevent blood penetration”

3.ASTMF1671 / F1671M-2013 “Test method for phage penetration resistance as a test system for measuring the penetration resistance of protective clothing materials against blood-borne pathogens”

 

Standard instructions for exporting US anti-crown virus protective clothing:

ASTM F1670 Synthetic Blood Penetration Test (for Surgical Sheets) No Penetration at 2 psi (13.8 kPa) Blood and Virus Penetration Resistance (2 psi)

 

ASTM F1671 Viral Penetration Test (for Surgical and Isolation Clothing No Penetration at 2 psi (13.8 kPa) Blood and Virus Penetration Resistance (2 psi)

From the above data, it is clear that the requirements for the level of protective clothing against coronavirus are the fourth-highest level, and importers must pay attention.

 

EU protective clothing EN14126 standard

EN 14126: 2003 + AC: 2004 “Performance requirements and test methods for protective clothing against infections” The standard applies to reproducible and limited use of protective clothing but is not suitable for surgeons and patients to avoid cross-infection during surgery Wear it. It is required that the joints of protective clothing shall meet the strength requirements in EN 14325 “Test methods and performance classification of chemical protective clothing materials, sutures, joints, and combinations”. The entire protective clothing is divided into 6 categories according to the protective performance, from type1 to type6, the smaller the number, the higher the protection; type 4 is a medical recommendation, the type with “B” is biological protection, and generally the type B protective clothing is preferred.

 

Standard instructions for exporting European protective clothing against the new crown virus:

According to China’s “Notice of the General Office of the National Health and Health Commission on Strengthening the Management of Medical Protective Equipment During the Epidemic Period” during the fight against the new crown epidemic, medical institutions can use emergency medical supplies protective clothing during the epidemic prevention and control period when medical protective clothing is insufficient. Emergency medical supplies protective clothing should meet EU medical protective clothing EN14126 standard (where the liquid barrier level is above level 2) and obtain EU CE certification, or liquid dense protective clothing (type3, meet EN14605 standard), spray dense protective clothing (type4, Meets EN14605 standard), anti-solid particulate protective clothing (type5, meets 1SO13982-1 and 2 standards). Protective clothing for emergency medical supplies is only used to isolate and observe the ward (room), isolation ward (room), and cannot be used to isolate places such as intensive care units (rooms) with strict microbiological index control.

 

 

Chinese national standard GB19082-2009 “Technical Requirements for Disposable Protective Clothing for Medical Use” The anti-synthetic blood penetration level requirement of “second-level protective clothing” is no penetration at a pressure value of 1.75kPa. Such protective clothing is used in Chinese hospitals to fight the new crown For the pneumonia epidemic, the European standard is compared with Chinese GB19082-2009. The corresponding European standard adopted ISO 16604, which is also level 2 or higher. Therefore, it is exported as a protective fabric for medical protective clothing that protects the human body against new types of coronavirus invasion. It should be certified according to EN 14126 and should reach a higher level in ISO 16604, ISO 22610, ISO 22611 (of which ISO 16604 is at least level 2).

Based on the comparison between the Chinese national defense epidemic experience and the Chinese and European standards, it can be seen that to combat the new crown pneumonia epidemic, at least type 5 European standard protective clothing must be used in emergency situations. In areas such as hospitals with a higher risk of virus infection, the medical protective clothing used is at least type 4 Above the level, the type1-5 protective clothing has the greatest demand in epidemic prevention and control and patient treatment.

 

Type 6 protective clothing has no technical requirements for the seams, so the seams and pinholes will cause the penetration of contaminated liquid, which is not suitable for the new type of coronavirus protection.

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.

 

 

Japanese protective clothing technical standards

Japan’s personal protection standards are classified as the labor safety category of T safety standards for medical safety appliances in Japanese national standards. Among them, JIS standards are the most authoritative and important standards in Japanese national standards, and they are non-mandatory standards. However, if it is cited by Japanese law, the JIS standard may become a mandatory standard.

 

Standard instructions for exporting Japan’s new crown virus protective clothing:

There are 45 standards related to protective clothing in the JIS standard. Among them, Japanese JIS T 8122: 2015 (protective clothing for the prevention of dangerous biological agents) combines chemical protective clothing standards with anti-infective protective clothing standards, and its core standard is JIS T 8115 (Chemical protective clothing), JIS T 8060 (Protective clothing to prevent contact with blood and body fluids-Method for measuring the permeability resistance of protective clothing materials to blood and body fluids-Test method using artificial blood), JIS T 8061 (Protection against blood Protective clothing for body fluids-Method for measuring the permeability resistance of protective clothing materials to the blood-borne pathogens-Test method using Ph-X174 phage). Therefore, protective clothing that complies with Japanese JIS T 8122: 2015 standards can be used for medical treatment and treatment of new crown pneumonia epidemics.

 

Technical standards for the production of protective clothing in various countries

International protective clothing standards:

ISO 16603: 2004 EN

Protective clothing against contact with blood and body fluids. Determination of the permeability of protective clothing materials against blood and body fluids. Test method using artificial blood

 

ISO 16604: 2004 EN

Protective clothing against contact with blood and body fluids. Determination of the permeability of protective clothing materials against blood pathogens. Test method using Phi-X 174 phage

 

ISO 22609: 2004 EN

Protective clothing for infectious agents. Medical masks. Test method for preventing the penetration of artificial blood (fixed volume, horizontal injection)

 

 

ISO 22612: 2005 EN

Protective clothing against sensory pathogens-Test method for resistance to dry microorganism invasion

 

IEC 61331-3-2014

Protective devices against medical X-rays. Part 3: Protective clothing, goggles, and patient protection

 

European protective clothing standards:

EN 14126-2003

Protective clothing. Performance requirements and test methods of anti-virus protective clothing

 

EN ISO 22612: 2005

Protective clothing against sensory pathogens-Test method for resistance to dry microorganism invasion

 

EN 61331-3: 2014

Medical diagnostic x-ray protective equipment. Part 3: Protective clothing, goggles, and patient protection

 

American Protective Clothing Standard:

ASTM F903-2018

Standard Test Method for Liquid Penetration Resistance of Protective Wear Materials

 

ANSI / PB70-2012

Liquid barrier properties and classification of protective clothing and protective layers intended for use in healthcare facilities (FDA approved)

 

ANSI / NFPA 1999-2008

The standard for Protective Clothing for Emergency Medical Surgery

ASTM F1670 / F1670M-2017a

Standard Test Method for Resistance of Protective Clothing Materials to Synthetic Blood Penetration

 

ASTM F1671 / F1671M-2013

Standard Test Method for Impervious Materials Used in Protective Clothing for Bloodborne Pathogens Using Phi-X174 Phage Penetration as a Test System

 

ASTM F2878-2019

Standard Test Method for Resistance of Protective Clothing Materials to Subcutaneous Puncture

 

ASTM F3050-2017

Guidelines for conformity assessment standards for personal protective clothing and equipment

 

NFPA 1999-2018

The standard for Protective Clothing and Clothing for Emergency Medical Services

 

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 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!)