We’re sharing information about Chinese face mask and respirator regulations and certifications and information about exporting from China (which is changing rapidly) so importers of coronavirus supplies have a better understanding about buying from China.
Page last updated: 9/5/20
1. Mask Types
China’s face mask testing standards and some of the naming conventions are different from the rest of the world.
Unlike other areas and countries which make a fairly strict distinction between medical masks and PPE (like respirators), China’s main distinction is between face masks FOR medical use, and those which are NOT for medical use.
You can see them in this table in which medical use face masks and their applicable pharmaceutical standards are highlighted (source):
For medical use you will find that there are 3 key types of face mask:
- Medical surgical masks
- Ordinary grade disposable medical masks
These two mask types are typically made of 3-ply paper and are single-use. They are designed to protect others primarily, although as a barrier, they do provide limited protection for the wearer against splashes, droplets, and some aerosols (PPE are designed specifically to provide protection).
- Protective masks for medical use (these are commonly known as ‘respirators’ or ‘N95 masks’ in the USA)
PPE respirator masks are specifically designed to protect the wearer from very small particles as they are made from filtering material and provide a much closer ‘seal’ around wearer’s nose and mouth. As a face covering, they do also provide protection for others, but this is not their primary purpose.
How about masks for non-medical usage?
These masks are a mixed bag. They may look like medical masks, but they are not held to the same pharmaceutical standards as those used in healthcare applications.
Others are commonly called ‘barrier’ or ‘scavenger’ masks, these masks are non-medical use masks used to provide some protection for the wearer and others against coronavirus infection. They are typically made from black fabric, but can be other colors:
None of these masks are within the scope of MD or PPE and do NOT conform with their relevant standards.
Therefore when importing the masks, if you do not see the Chinese or Foreign standards on the packaging, it may be that you have received these non-medical use masks which must not be sold as protective equipment or for use in healthcare settings.
The correct standards should be on the mask packaging so it’s important to check the box, BUT, of course, this can be (and is often) faked, so importers should also perform due diligence on the supplier, the supplier’s certifications, and their operations (by auditing the factory if possible).
2. Medical Face Mask Regulations
Face masks for medical use must conform to the following standards:
- Medical Surgical masks conform to China FDA’s YY 0469-2011 standard for Protective Face Mask for Medical Use applicable to disposable masks worn by clinical medical personnel during invasive operations.
- Disposable Medical masks conform with YY/T 0969-2013 standard for Single-use medical face masks.
As medical products, the manufacturer should be registered on the official website of the China Medical Products Administration.
What’s the difference between these 2 mask types?
The difference between surgical masks and disposable medical masks is largely one of the materials.
They are both usually 3-ply, but in surgical masks, the outer layer protects against liquid droplets and splashes, the middle filtering layer uses melt-blown non-woven material to stop very small particles from passing through with the wearer’s breath, and the inner layer absorbs moisture from the wearer’s breath (image source).
A disposable medical masks’ outer layer is less liquid-resistant than that of surgical masks, but they look ostensibly the same in appearance.
3. Protective face masks for medical usage regulations (PPE respirators)
These PPE protective face masks for medical use will conform to one of 2 standards which are applicable to the setting in which they will be used:
Hospital-specific N95 masks
GB 19083-2010 Technical Requirements for Protective Face Mask for Medical Use.
As well as providing filtration and protection from airborne aerosol particulates, the material of the outer surface of the mask will also be able to block body fluids from splashing and penetrating (like medical use surgical masks’ outer layer). They should also conform with American NIOSH standards for respirators, too.Non-Hospital-specific N95 masks
GB 2626-2019 Respiratory protection – Non-powered air-purifying particle respirator (this replaces GB 2626-2009) is a rough equivalent of the USA’s NIOSH N95 standard and is the appropriate standard for non-hospital specific protective face masks that are not tested for fluid resistance in the same way.
Unlike Europe where PPE masks are named FFP1, 2, and 3, Chinese PPE respirators are more closely related to American naming conventions and regulations (which are prefixed by ‘N’).
They’re classified by filtration effectiveness of a percentage of particles whose diameters are greater than 0.3 µm.
- KN90 (non-medical use only)
- KN95 (%)
- KN100
Again, manufacturers of PPE protective face masks for medical use should be registered on the National Medical Product Administration website.
4. Export information for Chinese face masks and respirators
Can Chinese-certified face masks be imported into the USA or Europe without passing local standards due to the coronavirus?
Yes, temporarily.
Both the USA and Europe have relaxed regulations and will allow foreign medical devices and PPE (like respirators) to be imported without complying to their own internal regulations, such as FDA regulations or harmonised European standards, providing that they reach the correct standard for their country of origin or those recommended by the WHO.
Read the FDA’s Declaration about this here.
Read the EU’s declaration about this here.
Note that as of May 7th 2020, this list of authorized non-NIOSH approved respirator manufacturers has been cut from around 80 to just 14 due to ongoing quality issues where KN95 masks that have reached the USA have not reached minimum safety standards, i.e. did not filter at least 95% of particles from the air.
In the context of importing from China, it is important to check that the masks at least conform to Chinese standards before exporting them. Note: Only these Chinese testing laboratories are authorized to test medical face masks and PPE.
Read more about this here: Face Mask Regulations and China Export Challenges For Buyers During The Coronavirus Pandemic
What should importers know about exporting from China?
Exporting masks from China has become a lot more difficult at the time of writing this page (April 22nd 2020).
A timeline on why China tightened medical product & PPE export regulations
- In January and February 2020, China battled coronavirus domestically and medical supplies and PPE were being imported into China from abroad as well as increasing domestic production to feed their high demand.
- In March as China’s outbreak started to settle down, the opposite was happening in the rest of the world, especially in Europe and North America. At this point, the demand for exported Chinese medical supplies and PPE skyrocketed and many new ‘small’ suppliers entered the market and started producing in-demand products.
- Reports started surfacing about defective PPE and medical items being rejected by countries where the need was grave, perhaps due to smaller suppliers’ products non-compliance with Chinese or international standards:
- In response to this, starting from April 1st, the Chinese government, who really don’t want to ‘lose face’ and wish to provide high-quality products to the world have tightened export requirements for items like masks.
Where are we now with exporting from China?
The Chinese government has changed its policy for allowing PPE products and related medical devices to be exported. Then again on 10 April (with no advance notice, seemingly). Then they adjusted it without publishing clarifications. Many shipments have been suddenly prevented by Chinese Customs. As long as the situation is not clearer, we cannot write a clear guide.
Roughly, as an importer, you need to check the following:
Your supplier must be licensed in China to manufacture medical products.(This requirement has now been revoked by the government as of 4/26/20)- They must be authorized to export that product from China (the requirements surrounding this are changing rapidly, but it includes most PPE).
- The paperwork submitted to China Customs is 100% correct and double-checked (they are scrutinising it strictly for errors or inconsistencies).
- The products are of good quality and not counterfeit (they are checking the quality at customs & performing factory inspections).
- The importing country is legally permitted to receive such items.
As of 26 April 2020, importers now need to complete this joint declaration form where you take full responsibility for any issues arising from the use of the face masks you import from China. To be clear, the Chinese supplier is absolved of any responsibility if face masks intended for non-medical use are used in a medical setting and safety issues occur.
As you can imagine, this is causing delays and uncertainty.
Sofeast’s indemnity and notes for the reader
- We are not legal professionals and any information provided here about the regulations and standards is only given for your reference. We do not accept responsibility for any issues you may face after using this information.
If you are unsure about the validity of your face masks, please refer to the Chinese official documentation, Chinese notified testing body, or a local legal professional for assurance before purchasing face masks or other medical items. - This page will be updated periodically as we find useful new information. If you have a suggestion for a change or an addition, please contact us.
