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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?
Here’s a quick sneak peek to the answers:
1. Find a supplier of masks who already has the necessary certifications.
2. On top of Packing List and Commercial Invoice, you’ll need NIOSH or FDA certification to import into the US, CE certification for Europe, or TGA certification if importing into Australia.
3. Be aware of the tariff situation for medical supplies for your particular country - some have no tariffs for medical supplies.
Read ahead for full 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) | Surgical Mask | N95 Respirator | Surgical N95 Respirator | |
|---|---|---|---|---|
| Image |  |
 |
 |
 |
| 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 |
** As certified by National Institute for Occupational Safety and Health (NIOSH)
# Proper fit of respirators is verified by respiratory fit testing as per Singapore Standard 548:2009: Code of Practice for Selection, Use and Maintenance of Respiratory Protective Devices.
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:
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 |
|---|---|---|
| Packing 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.  |
FDA registration permission Must obtain US FDA registration.  |
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 |
|---|---|---|
| Packing 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.  |
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.
 |
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 |
|---|---|---|
| Packing List | Need | Need |
| Commercial Invoice | Need | Need |
| Certifications | TGA
 |
TGA
|
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.
Proud Co-Founder and CEO of Bookairfreight. Shortly after starting to work in the world of logistics, I was astonished at how difficult and time consuming it was for businesses to get their hands on a simple air freight quote. I saw this as an opportunity to really make a difference in people’s lives, and felt like I had to do something. It was the spark that lit the fire of Bookairfreight’s creation.
