The spread of COVID-19 sees skyrocketed demand for personal protective equipment (PPE) in international markets. Disposable coveralls are vital for medical staff because of their antibacterial property and blood resistance, thereby containing the spread of infectious disease. Yet the sudden outbreak leads to a desperate shortage of supply across the globe. Front liners and healthcare workers who fight against the disease lack a sufficient supply of protective equipment such as medical gowns to carry out their responsibilities safely. As such, the world is looking to China’s supply capacity for producing protective suits at large volumes to meet escalating demand.
China offers a multitude of efficient suppliers that have years of experience in manufacturing PPEs, such as disposable shoe covers and coveralls. The mature supply chain, complete infrastructure, and expertise of Chinese manufacturers have allowed possibilities to construct mass production of protective suits at a rapid rate. Famous automotive companies even shifted their production lines into manufacturing protective suits. However, there are concerns as to how sellers can guarantee the quality of Chinese medical gowns.
You will not have to worry about the quality of Chinese medical gowns because of the measures taken to ensure quality. All manufacturers and suppliers are mandated to acquire certifications to guarantee the efficient import of Chinese medical gowns to other countries, according to the country’s Ministry of Commerce. Manufacturers will not be allowed to export those pandemic-fighting goods until they meet the requirements of the regional market.
On April 1, 2020, the Chinese Ministry of Commerce, the General Administration of Customs and the State Administration of Drug Administration jointly announced that suppliers must acquire a medical device product registration certificate that confirms the qualification of medical supplies being exported.
For foreign buyers, besides relying on the strict regulations, you need to ask for the documents listed below for further verification:
→ Invoice, packing list, contract, entrust letter of customs declaration agent (or electronic version);
→ Medical device operating license (applicable to medical devices);
→ Test report (CMA, CNAS) and qualification certificate (factory inspection list) (applicable to medical devices);
→ Additional documentation required by the customs.
The information on regulations we collect for you will also help you to import protective clothing from China more smoothly. Each country has a specific certification requirement that you and your manufacturing partners need to comply with.
Quality assurance requirements differ for every country to regulate imported goods to be used in helping patients and healthcare workers alike during the COVID epidemic. We begin by looking at the standards employed by China.
Commodity classifications are given to most protective suits made from chemical fiber, rubber, and plastic. The certification needed is similar to face masks because all protective coveralls will go through a thorough inspection process and must be provided with product manuals for proper usage. The testing methods provided by the government include liquid barrier, microbial and synthetic blood penetration tests.
China has also signed over 17 free trade agreements in order to export to 25 different regions. As such, Chinese imports receive tariff reductions when suppliers provide certificates of origin before exporting. Additionally, much like facial masks, protective suits have an export tax rebate rate of 13%. For buyers, this means that Chinese products are imported at cheaper costs and can be shipped quickly when they meet the requirements. At the same time, the prices offered by Chinese suppliers are quite competitive within the global market.
Along with the national qualifications and certifications for Chinese suppliers, imports are subject to a variety of conditions placed by different countries. To name a few, the United States of America, Europe, Japan, Korea, Australia, and Iran have different requirements that must be met prior to importing goods to their respective markets.
The US Food and Drug Administration (FDA) requires Chinese manufacturers to apply all surgical protective coveralls for FDA 510 (K). The FDA categorizes protective suits into two categories: non-surgical and surgical protective clothing. Of the two categories, surgical medical gowns require pre-market registration. The United States uses ANSI / AAMI PB70: 2012 standards in classifying medical gowns into the following categories:
|Class I||Isolation gown||• It is labeled as a gown other than a surgical gown(eg, isolation gown);|
• It is not described in its labeling as a surgical gown; and
• If it has statements relating to barrier protection: ANSI / AAMI PB70 Level l protection or equivalent; or ANSI / AAMI PB70 Level 2 protection or equivalent.
|Class II||Surgical Gown:pre-market registration is required, i.e. FDA 510 (K)||• It is labeled as such;|
• It is described as such in its labeling;
• It has statements relating to moderate or high levelbarrier protection:ANSI / AAMI PB70 Level 3 protection or equivalent; or ANSI / AAMI PB70 Level 4 protection or equivalent
Moreover, the American National Fire Protection Association Standard NFPA 1999-2018 divides the degree of protection offered by medical gowns to four specific areas: head, body, hands, and feet. Within the standard, medical gowns are tested for their flame retardance and physical strength in order to determine how well they work for both medical staff and emergency response groups, such as firefighters. Most surgical gowns are tested for their waterproofness and antibacterial properties to counter infection.
European importers who want to purchase protective overalls from China should require manufacturers to provide their EU/CE certification. The standards (EU)2016/425 particular attention to a number of safety features and technical points that importers must follow.
※ Ensure that their products meet the regulations listed in Annex Ⅱ basic health and safety requirements. This means all products must have ergonomic designs and a risk assessment must be conducted prior to manufacturing.
※ Write the regulations in Annex Ⅲ technical documents;
※ Carry out applicable compliance assessment procedures;
※ Write a declaration of EU compliance;
※ Attach the CE mark to the product in accordance with regulations
※ Mark the manufacturer’s name, registered trade name or registered trademark, address, etc. on;
※ Attach the type, batch or serial number for easy identification on personal protective equipment
※ Write instructions for use, provided with personal protective equipment. The instructions for maintenance and disinfection are to be included in the delivery of any protective suits and connected to the attached EU Declaration of Conformity.
After 10 years in the market, manufacturers must guarantee that they keep their EU compliance statement and technical documents to secure the trust of the market.
Labeled within the T labor safety category, medical gowns brought into Japan must meet the requirements of the Pharmaceutical and Medical Device Act (PMD Act). Chinese manufacturers must provide their manufacturer information with PMDA. The following are the authoritative Japanese Industrial Standards (JIS) to be followed:
|JIS||ISO||Standards for PPE|
|JIS T 8062:2010 (MOD)||ISO 22609:2004||Clothing for protection against infectious agents—Medical Facemasks-Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)|
|JIS T8005:2015 (MOD)||ISO 13688:2013||Protective Clothing – General Requirements|
|JIS T8060:2015 (MOD)||ISO 16603:2004||Clothing for protection against contact with blood and body fluids—Determination of the resistance of protective clothing materials to penetration by blood and body fluids—Test method using synthetic blood|
|JIS T 8061:2015 (MOD)||ISO 16604:2004||Clothing for protection against contact with blood and body fluids—Determination of the resistance of protective clothing materials to penetration by bloodborne pathogens—Test method using Phi-X174 bacteriophage|
The consignee within South Korea must register the import qualification with the Korea Pharmaceutical Traders Association before import. The national government announced through the Ministry of Labor the Announcement on January 15, 2020 No. 2020-35 “Notification of Safety Certification of Protective Equipment”. This statement provides performance standards and inspection requirements for protective clothing such as medical gowns. The Safety Certification divides protective suits into six different classes:
→ Class 1: Integrated protective clothing with internal or external positive-pressure breathing apparatus
→ Class 2: Integrated protective clothing with positive-pressure breathing apparatus
→ Class 3: Liquid-proof protective clothing
→ Class 4: Anti-spray protective clothing
→ Class 5: Anti-dust protective clothing
→ Class 6: Liquid Splash Resistant Protective Clothing
Chinese manufacturers must be registered to Australia’s Therapeutic Goods Administration (TGA). The TGA regulates the importation of medical equipment and divides medical devices into Class I, Is and Im, IIa, IIb, and III, which all go through a compliance review process and approved by the Australian government. Additionally, TGA certification can be acquired by submitting CE certification. Manufacturers registered under the EU can avail of TGA certification faster than usual.
Manufacturers must consider following are the equipment standards for Australia:
|AS 3789.7-1996 Textiles for||Health care facilities and institutions-general clothing|
|AS 3789.3-1994 Textiles for||Medical facilities and institutions-operating room staff clothing|
|AS 3789.2-1991||Medical facilities And institutional textiles-linens and pre-packaged|
|AS / NZS 4501.2-2006||Occupational protective clothing-general requirements|
According to the Chinese General Administration of Quality Supervision, Inspection and Quarantine’s Announcement No. 161 of 2011, the Iranian Institute of Standards and Industry will go through the verification and release procedures of Chinese industrial products exported to Iran with the pre-shipment inspection certificate. Manufacturers must apply to the local entry-exit inspection and quarantine agency and must carry out the requirements and schedule listed in the “Regulations on Entry-Exit Inspection and Quarantine”.
The Iranian standards of protective equipment are the following:
|ISIRI 17123-2019||Protective clothing to prevent infectious agents-Test for blocking the penetration of dry microorganisms|
|ISIRI 21400-2017||Protective clothing-Determination of protective gloves dimethyl formamide|
|ISIRI 17128: 2019 (IDT ISO 13995: 2000)||Protective clothing-Mechanical properties-Test method for determination of puncture resistance and dynamic tearing of materials|
|ISIRI 22458-2018||Protective clothing-chemical protection-protective clothing materials resistant to liquid and gas penetration Determination|
To find the manufacturers complying with the different certifications and requirements, you will need the support of KP. We represent hundreds of high-end manufacturers that have the capabilities to meet the rising demand for medical gowns worldwide. Our services provide you with a fast means to secure the trust of your growing market.
We offer a list of KP-verified manufacturers and suppliers that have been certified and registered in different regions and countries. Medical gowns from such manufacturers have been tested for their efficiency, barrier protection, and pathogen resistance to ensure the safety of your end-users. Additionally, our suppliers are effective in delivering goods on time and comply with our partnership agreements to secure your trust.
Grow your business with KP Medical Supplies and our one-stop-shop solutions for your import needs. We are your helpful industry partner that connects you only to the most reliable manufacturers of medical gowns the medical industry needs. Our referral trusted law firms allow you to seek support for dispute resolution and risk management for your trade concerns. To help you get medical gowns on schedule, we recommend high-end shipping companies that are trusted for their fast service.