The Ultimate Guide to Importing Masks From China

07/04/2020
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Spain, Italy, and other countries that are being severely hit with the Coronavirus pandemic see a rapid increase in protective face mask demand. Spain saw a dramatic spike in demand of 10,000% for face masks from January 2019 to January 2020. The prices for disposable face masks in Italy also saw the same growth rate in terms of online prices from 10 cents to 10 euros per piece.

Many N95 face mask manufacturers in China are working to fulfill the rising demand around the world. However, certain countries are citing concerns over the quality of disposable face masks. To alleviate the concerns, the Chinese government is taking proactive measures by ensuring the quality of each protective face mask exported from the country. The government is also working on creating smooth customs clearance for foreign buyers. 

Masks-factory
Masks factory

With the rising demand for quality protective face masks, you can tap into different regions through the right Chinese exporters. Read on to know how to import masks from China while complying with the requirements of your target markets. 

China’s Effort To Addressing Quality Concerns

Chinese manufacturers need certifications to comply with health and safety standards of specific regions such as the FDA for the US markets. With the recent rules set by the Chinese government, face mask suppliers around the country must have the approval of the National Medical Products Administration on top of having the right certificates for specific countries. 

A-worker-checking-the-quality-and-package-of-the-protective-face-masks
A worker checking the quality and package of the protective face masks

For custom clearances, nearly every protective and medical face masks are under tariff number 63079000 in terms of commodity classification. Should the disposable face mask be considered trade nature, tax declarations can be levied following the regulations. Given the pandemic situation, all masks are considered illegal quarantine products and are required to be inspected before sampling following the agreement between the Chinese and recipient country. 

Suppliers are required to write the name of the protective face mask and its composition as stated by the requirements of declaration. In the case of US companies, they can apply for tariffs exclusions when importing masks. However, only a handful of organizations are exempted. 

Violators of China’s rules and regulations for importing disposable face masks will face property fines, qualification fines, free fines, and other forms of financial repercussions. Exporters also risk periodical or indefinite suspension of their business. The Chinese Government is stepping up their surveillance on exporters to ensure every supplier comply with their rules.

Manufacturers and traders must also have the following:

Licenses 

Business licenses with a scope that covers the manufacturing of medical face masks are expected among suppliers. They must also possess an enterprise production license. 

✔ Product Inspection Report

The report consists of the AQL level of each Surgical or N95 face masks based on the sample size from a specific package. AQL indicates the number of defects found among the sample size.

Medical Device Registration Certificate

The certificate is required for medical face masks. However, any protective face masks used for different purposes does not require this certificate. 

✔ Product manuals, labels, and batch/number

Each protective face mask packaging must contain manuals or documentation that provide all the necessary information about the product. Informative details should also be stated on the product such as the classification and certificate of the medical mask. The packaging must provide the batch number of the product. 

✔ Quality and safety certificate

The necessary certification details must be stated on the product. Various countries will have different certifications on disposable face masks. 

Sample and packaging pictures

The pictures allow for quick visual verification of the manufacturer’s medical face mask. 

Trade contract

Exporters must have a trade contract with a signature from their representative and the buyer.

Certifications and Classifications for Face Masks

Understanding the requirements and classifications set by each country is important when importing protective face masks from China to specific regions. It is also important to note that personal protective and medical masks will have different certification requirements. 

To give you a clear picture of what you need to know in importing face masks from China, here are the certificates and classification requirements across major countries. 

EU

CE certification is required when exporting medical face masks to the EU. Fortunately, you do not need a free sales certificate when exporting protective face masks from China to the region. Buyers also require the bill of lading, packing list, and invoice for every order of protective mask. 

Protective Face Mask

The EU classification of protective face masks is EN 149. To meet this standard, the mask must be capable of filtering particles. The product has 3 different classes for these masks:

FFP1  At least 80% filtration capabilities, and 22% leakage behind the mask. 

FFP2 Has a 94% filtration rate and up to 8% leakage rate. 

FFP3 Superior filtration rate of 99% with only 2% leakage. 

FFP3-Protective-Face-Mask-in-the-EU-Market
FFP3 Protective Face Mask in the EU Market

Medical Mask

All medical face masks classification in the EU is EN14683. Type I surgical masks must have a bacterial filtration efficiency or BFE =>95% while Type II requires a BFE =>98%, ensuring the. For masks that are specified to be splash, resistance must prevent at least 120 mmHg from penetrating the mask. The breathing resistance of Type I masks must be more than  29.4 Pa/cm2 or more while type II masks should have a resistance of 49 Pa/cm2 or greater. 

US

In the US, masks need to be certified by the National Institute for Occupational Safety and Health Certification(NIOSH). Medical masks must be registered with the US’ Food and Drug Administration. Each order of disposable face masks requires a packing list, invoice, and bill of lading. 

Protective Face Mask

All protective face masks that filter airborne particles are N95 respirators. Most disposable masks with this mark are intended for protection against dust and other small particles.  For protection against bacteria or viruses, N95 class II masks are capable of filter microorganisms. 

N95-Protective-Face-Mask-in-the-US-Market
N95 Protective Face Mask in the US Market

Medical Mask

Most medical face masks in the US are classified as ASTM F2101-07 by the American Society of Testing and Materials. Much like the EU, these masks have two different types with type I having a BFE =>95% and type II with its BFE =>98% capabilities. Medical masks with a classification of ASTM F1862-07 have splash resistant quality and are required to prevent at least 120 mmHg of fluid from penetrating the interior space. 

South Korea

All protective face masks exported to South Korea need to comply with the Ministry of Food and Drug Safety Notice No. 2015 -69 rules. Importers require a Korean importer business license on top of the bill of lading, packing list, and an invoice of face mask orders. 

 Protective Face Mask

Protective face masks are categorized into three types based on their filtration capabilities.

KF80 80% dust collection efficiency and 6.2 mmH20 facial inhalation resistance

KF94 94% dust collection efficiency and 7.2 mmH20 facial inhalation resistance

KF99 99% dust collection efficiency and 10.3 mmH20 facial inhalation resistance

KF94-Face-Masks-in-the-Korean-Market
KF94 Face Masks in the Korean Market

Medical Mask

Under the MFDS, all medical face masks fall under medical device regulations as indicated by the Medical Device Act. Medical masks are categorized as either Class I, II, III, IV based on their risk level. Class I masks having little risk to patient’s health while Class IV having the highest risk possible. 

Japan

Chinese suppliers must comply with Japan’s Pharmaceuticals and Medical Devices Agency regulations and be registered for their manufacturing information with the agency. Packaging of the masks must have the particle filtration efficiency (PFE), bacterial filtration rate (BFE), and virus filter rate (VFE) of the product.

Protective Face Mask

N95 masks must meet the NIOSH certification standards while KN95 complies with Chinese GB 2626 STANDARDS. Both types are expected to have a non-oily filtering efficiency of ≥95%.

Medical Mask

Suppliers need to ensure their medical protective masks follow the Chinese GB 19083-2010 standards. Like protective face masks, medical masks must have a ≥95% non-oily filtering efficiency.

Australia

Registering with Australia’s Therapeutic Good Administration and complying with the organization’s regulations is required for every face mask supplier in China. Any protective face masks that have the CE certificate, the TGA recognizes it since Australia follows the EU classification.

Protective Face Masks

Nearly all protective face masks in Australia are classified as respiratory protective equipment (RPE), specifically particulate filters. The country classifies these masks into P1, P2, and P3 with the highest having the best filtration performance.

P2-Protective-Face-Mask-in-the-Australian-Market
P2 Protective Face-Mask in the Australian Market

Medical Masks

Each medical mask must pass the AS/NZS 1716:2012 standards for respiratory health within the country. New Zealand also shares the same standards for protective face masks. Since Australia follows the EU standards, CE certified masks follow the EU classifications for medical masks. 

To ensure a supplier’s qualification, you can request specific documentation from a supplier such as a written or electronic declaration from a protective face mask supplier. Customs personnel can verify a establishments’ declaration for you. You can look up qualified suppliers on the National Medical Products Administration, Ministry of Commerce, and General Administration of Customs website to verify the legitimacy of their operation. 

As mentioned above, you need to ensure the supplier has the right certifications for your target markets such as CE for EU or FDA for the US. Make sure to ask for documents for customs clearance as well to avoid any issues when importing quality protective masks. 

Matching Standards with a Country’s Certificate

Protective-Face-Masks-for-the-Globe
Protective Face Masks for the Globe

Standards Applied in China

Features & StandardsGB 19083-2010Medical face maskYY0469-2011Surgical face maskYY/T 0969-2013Disposable medical face maskGB2626-2006Protective respirator
Filtration Efficiency(FE)FE on non-oily particles (at 85L/min airflow)
class 1 Filters ≥ 95% of airborne particles.
class 2 Filters ≥ 99% of airborne particles.
class 3 Filters ≥ 99.97% of airborne particles.
4.6.1 BFE(Bacterial filter efficiency) ≥ 95%  
4.6.2 PFE(Particle l filter efficiency) ≥ 30%, on non-oily particles
4.5 BFE(Bacterial filter efficiency) ≥ 95% Performance in NaCl particle test
KN90 Filters ≥ 90% of airborne particles.
KN95 Filters ≥ 95% of airborne particles.
KN100 Filters ≥ 99.97% of airborne particles.
TigthessTotal fitness factor ≥ 100\\Under 6.14 testing method Negative pressure drop within a full-face mask ≤ 100pa in 60 seconds.

Standards Applied in your country

Country/RegionCertificationFiltration Efficiency (FE)Tightness
USNIOSH 42CFR Part84 Respiratory ProtectionPerformance in NaCl particle test
N95 Filters ≥ 95% of airborne particles.
N99 Filters ≥ 99% of airborne particles.
N100 Filters ≥ 99.7% of airborne particles.
 
EuropeEN149:2001 Respiratory ProtectionClass Filter Penetration limit(at 95L/min air flow)
FFP1 Filters ≥ 80% of airborne particles.
FFP2 Filters ≥ 94% of airborne particles.
FFP3 Filters ≥ 99% of airborne particles.
Inward Leakage
FFP1 <25% inward leakage
FFP2 <11% inward leakage
FFP3 <5% inward leakage 
South KoreaMFDS notice No 2015-69 Respiratory ProtectionPerformance in NaCl particle test
KF80 Filters ≥80% of airborne particles.
KF94 Filters≥94% of airborne particles.
KF99 Filters ≥99% of airborne particles.
Inward Leakage
KF80 <25% inward leakage
KF94 <11% inward leakage
KF99 <5% inward leakage
JapanJIS T8151:2005 Respiratory ProtectionPerformance in NaCl particle test
DS3 Filters ≥ 99.9% of airborne particles.
DS2 Filters ≥ 95% of airborne particles.
DS1 Filters ≥ 80% of airborne particles.
 
RussiaGOST 12.4.294-2015 Respiratory ProtectionFFP1 Filters ≥ 80% of airborne particles.
FFP2 Filters ≥ 94% of airborne particles.
FFP3 Filters ≥ 99% of airborne particles.
Inward Leakage
FFP1 <25% inward leakage
FFP2 <11% inward leakage
FFP3 <5% inward leakage
AustraliaAS/NZS 1716-2012 Respiratory ProtectionClass Filter Penetration limit(at 95L/min air flow)
P1 Filters ≥ 80% of airborne particles
P2 Filters ≥ 94% of airborne particles
P3 Filters ≥ 99.95% of airborne particles
Inward Leakage
P1 <22% inward leakage
P2 <8.0% inward leakage
P3 <0.05% inward leakage

How KP helps you Find Face Mask Suppliers?

KP online platform can connect you with premium suppliers of quality face masks in China. We welcome buyers from around the globe since our qualified suppliers can ship to almost any country. 

Before any of our partnered manufacturers can list their products on our website, they go through a thorough audit. We check on the performance and durability of their face mask as well as promptness in fulfilling orders and responding to inquiries. 

Our team also verifies the certificate of a suppliers’ disposable face mask, ensuring your capabilities to meet the rising demand among your target markets across the globe. When required, we work with globally recognized auditors to check on an establishment’s qualifications. KP can also refer you to a third-party auditor to inspect a suppliers’ products for full transparency. For any legal disputes, we can also refer you to reputable law firms. 

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