Tips for Shipping N95 Respirators and Surgical Masks (Face Masks)

As one of the main tools for preventing Coronavirus transmission, face masks have become the hottest item in global trade. And with worldwide production impacts, the global demand for them has totally skyrocketed.


Companies all over the world are turning to China to supply their face masks needs, but that brings out questions, such as:

1. What qualifications do companies need to import face masks?

2. What restrictions are in place?

3. What kinds of documentation is needed?

4. What are the country-specific requirements for importing face masks?

Read ahead for answers to all of these questions (and more)!


What kinds of face masks are out there?

People are surprised to find out that not all face masks provide protection against viral transmission. To actually be safe, the masks have to be either surgical masks or N95 respirators. Last year’s Burning Man mask won’t protect you!

And based on what these masks are used for, customs clearance will classify them as either personal items or medical items.

Types of masks and respirators

Face mask (cloth or paper masks)

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Surgical mask

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N95 respirator

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Surgical N95 respirator

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Medical device? No Yes No Yes
Purpose Protects the environment from the person wearing it by catching any large particles.
Does NOT protect the wearer from external fluids like saliva or blood.
Protects the environment from the person wearing it by catching any large particles.
Does provide a physical barrier for external fluids like saliva or blood.
Protects the wearer from small airborne contaminants.
Does not provide a physical barrier for direct contact with fluids.
Provides the protection of both a surgical mask and N95 respirator.
Provides a barrier for direct contact with fluids as well as small airborne contaminants.
Fit Loose Loose Tight# Tight#
Filtration efficiency Does not fit tightly Bacterial filtration efficiency above 95%* Minimum 95%** against particulate aerosols (of 0.3 micron in size) free of oil Minimum 95%** against particulate aerosols (of 0.3 micron in size) free of oil.
Fluid resistance (i.e., resistance to penetration of bodily fluids) Not fluid resistant Yes Not tested for fluid resistance Tested to be fluid-resistant

How do I choose the right supplier?

Regulations, regulations, and, you guessed it, regulations!

Each country has their own when it comes to shipping medical items (which face masks fall under). To avoid a messy and complicated importing process, it’s important to choose suppliers that already have the necessary certifications.

Before placing the order

It’s extremely important to make sure your supplier has the proper documentation. If you’re working with a Chinese supplier, you can use the following translations to make sure they provide the proper information:

Item Qualifications and Documentations (EN) 国内出口贸易企业需具备的资质和材料
1 Business license (business scope
has relevant business content)
营业执照(经营范围有相关经营内容)
2 Enterprise production license (production enterprise) 企业生产许可证(生产企业)
3 Product inspection report (manufacturing enterprise) 产品检验报告(生产企业)
4 Medical device registration certificate
(not required for non-medical use)
医疗器械注册证(非医用不需要)
5 Product manual (provided with the product),
label (provided with the product)
产品说明书(跟着产品提供)、标签(随附产品提供)
6 Product batch / number (outer packaging) 产品批次/号(外包装)
7 Product quality and safety certificate or
certificate (provided with the product)
产品质量安全书或合格证(跟着产品提供)
8 Product sample pictures and packaging pictures 产品样品图片及外包装图片

Country-specific shipping requirements

Europe, Australia, and the United States all have different requirements when shipping face masks. The next few sections will give you an idea of what information is needed for a successful import experience.

United States of America

The FDA (Food and Drug Administration Agency) creates and enforces the regulations around medical items in the United States. In order to qualify the facemasks as medical grade, they’ll need FDA registration.

Necessary Documentation Personal Protective Mask Medical Masks
Packaging List Need Need
Commercial Invoice Need Need
Certifications NIOSH test certification
Must obtain the US NIOSH test certification,
the National Institute for
Occupational Safety and Health certification.

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FDA registration permission
Must obtain US FDA registration.

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US companies can also apply for the exclusion of tariffs on the import of masks. See the U.S. Trade Representative's website at https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05451.pdf

Notably:

"In accordance with the October 24 notice, the exclusions are available for any product that meets the description in the Annex, regardless of whether the importer filed an exclusion request. Further, the scope of each exclusion is governed by the scope of the 10-digit HTSUS subheading as described in the Annex, and not by the product descriptions set out in any particular request for exclusion."

Europe

The standards to watch for are EN149 and EN14683 - the former deals with personal protective masks (not medical grade) and the latter deals with medical grade masks.

Necessary Documentation Personal Protective Mask Medical Masks
Packaging List Need Need
Commercial Invoice Need Need
Certifications The EU standard for personal protective masks is EN149.

Masks are divided into three categories: FFP1 / FFP2 and FFP3.
All masks exported to the European Union must obtain CE certification,
which is a compulsory product safety certification system implemented by
the European Union to protect members of EU countries.

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The corresponding EU standard for medical masks is EN14683.
Products sold in the European Union need to issue the EU Free
Sale Certificate. With the CE mark and the EU registration
required by the relevant directives, Chinese manufacturers do not
need a free sales certificate to export to the EU.


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Making Sure CE Certification is Valid

When you’re shipping products to the EU, you need to make sure your manufacturer’s CE Certification is valid. We’ve written a full blog on this topic, so make sure to check it out HERE.

Australia

Must be registered by the Australian TGA and comply with the standard specification: AS / NZS 1716: 2012, which is the Australian and New Zealand respiratory protection device standard.

TGA stands for Therapeutic Goods Administration. It is the Australian regulatory body for therapeutic goods, including medicines, medical devices, genetic technology and blood products. Australian medical devices are classified into Class I, Is and Im, IIa, IIb, III. The product classification is almost the same as the EU classification. If the product has obtained the CE mark, the product category can be classified according to CE.

Necessary Documentation Personal Protective Mask Medical Masks
Packaging List Need Need
Commercial Invoice Need Need
Certifications TGA

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TGA

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Customs clearance/Tax and duty

A lot of countries are starting to eliminate tariffs for medical suppliers, and this is all moving fast! Please pay attention to the latest developments.

How to ship out

Bookairfreight has been shipping out face masks since March 2019.  We provide discounted DHL, UPS, FedEx shipping rates, as well as traditional air freight and chartered flights.

Based on our experience, we would recommend the following options depending on your volume. And as always, don’t hesitate to contact us at bookings@bookairfreight.com with any questions.

Weight Shipping Channel Transit Time
<300 KG(This is usually within 50,000 masks) Express couriers (DHL, UPS, FedEx) 5 - 7 business days
300 - 800 KG We would still recommend Express couriers,
but to ship as 2 batches.
Express couriers (DHL, UPS, FedEx)
5 - 7 business days
800 KG - 35 tons Traditional Air Freight Varies from 2-3 up to 10 days
> 35 tons Chartered airplanes Depending on the flight schedule,
1-2 days

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