How To Quickly Supply Non-Surgical Medical Face Masks to the US Market

Posted on April 21, 2020April 21, 2020 by Lee Wang

On April 20, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on certain medical face masks. This EUA streamlined and simplified prerequisite requirements for market certain medical face masks during the COVID-19 outbreak period in the US.

Types of Medical Face Masks This EUA Covers & Doesn’t Cover

This latest EUA from the FDA covers face masks meeting the following definition:

A face mask is a device, with or without a face shield, that covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. It includes cloth face coverings. It may be for single or multiple uses, and if for multiple uses it may be laundered or cleaned. There are many products marketed in the United States as “face masks” that offer a range of protection against potential health hazards. Face masks are regulated by FDA when they meet the definition of a “device” under section 201(h) of the Act. Generally, face masks fall within this definition when they are intended for a medical purpose.

More importantly, you need to pay attention to the type of medical face masks that this EUA does NOT cover:

Surgical masks are not covered within the scope of this authorization. Surgical masks are masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials and are regulated under 21 CFR 878.4040 as class II devices requiring premarket notification. Additionally, these masks meet certain fluid barrier protection standards and Class I or Class II flammability tests.

In summary, this FDA EUA covers face masks that are designed for medical use, either by the general public or by healthcare personnel (HCP), but exclude surgical masks.

Permissible Non-Surgical Medical Face Masks in the US

With this EUA, the FDA is now authorize the use of non-surgical medical face masks in the US, provided they meet the following criteria:

The product is labeled accurately to describe the product as a face mask and includes a list of the body contacting materials (which does not include any drugs or biologics);
The product is labeled accurately so that it does not claim to be intended for use as a surgical mask or to provide liquid barrier protection, and includes recommendations that would reduce the risk of such use; for example, the labeling might include recommendations against: use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high; and use in the presence of a high intensity heat source or flammable gas; or as an alternative example, recommendations for use only by the general public; and
The product is not labeled in such a manner that would misrepresent the product’s
intended use; for example, the labeling should not state or imply that the product is intended for antimicrobial or antiviral protection or related uses or is for use such as infection prevention or reduction, nor should it be used for particulate filtration.

Do My Non-Surgical Medical Masks Qualify For The US Market?

With this FDA EUA, as a non-surgical face mask manufacturer or distributor, you are required to complete the following before obtaining an authorization under this EUA to market your masks in the US.

You must have correct product labeling as a medical mask;
You must make sure your product label does not contain any mention or statement as a “surgical mask,” with liquid barrier protection and other surgical mask related claims;
You make required labeling available to each end user or end user, in print and online forms;
You must include instructions for recommended cleaning and/or disinfection materials and processes, in print and online formats;
You must have a process in place in the US for reporting adverse events to FDA under 21 CFR Part 803;
You must do record keeping: ensure that any records associated with this EUA
are maintained and made available to FDA for inspection upon request;
You must have a process of inventory control for the US customers in place and ready to be inspected by FDA;

How to Correctly Market Your Non-Surgical Face Masks in the US?

No false advertising!

When marketing and promoting your non-surgical medical masks in the US, you must make sure all your marketing and promotional materials are consistent with your non-surgical product labeling requirements listed above. For example, you cannot represent or suggest that your medical face mask is safe or
effective for the prevention or treatment of patients during the COVID-19 pandemic.

Furthermore, you should clearly state in your marketing materials that your non-surgical face masks

Are NOT FDA cleared or approved;
Are authorized by FDA under an EUA for use by HCP as PPE to help prevent the spread of infection or illness in healthcare settings and by the general public to help slow the spread of the virus during the COVID19 pandemic;
Are authorized only for the duration of the COVID-19 outbreak, with the FDA-required verbiage.

What Should Non-Surgical Face Mask Manufacturers and Distributors Do?

This latest FDA EUA enables non-surgical face mask manufacturers and distributors to skip the regular FDA Medical Device Class I registration/clearance process in order to market their products in the US market to help fight the COVID-19 outbreak. This being said non-surgical face mask manufacturers and distributors should go through these steps before they are import or market their products in the US:

STEP 1: Make sure you face masks are covered in this FDA EUA;

STEP 2: Make sure your face masks have a product label in English and they meet the labeling and other permissible requirements;

STEP 3: Make sure your product meets all the qualification criteria and you have required post-market process in place for US customers

STEP 4: Make sure you don’t have any inaccurate or false claims in all product materials and marketing collateral, in print and electronic alike.

GreenPPE team specialize in helping face mask and other PPE product manufacturers and distributors enter the US market, in particular utilizing this and other FDA EUAs and Enforcement Policies. We partner with you to get your products authorized for the US market, provide post-market turn-key support, and even link your products to US buyers.

Contact us as fast@greenppe.com and let us show you how to quickly supply your medical face masks and other PPE products to the US market.

What Are The New Rules for Exporting PPE and Other Medical Devices from China During the COVID-19 Outbreak?

Posted on April 3, 2020April 9, 2020 by Lee Wang

CHINA EXPORT QUALITY CONTROL

Effective April 1, 2020, Chinese exporters of medical products including COVID-19 testing kits, medical face masks, medical protective suits, ventilators and infrared thermometers are required to provide extra documentation to the Chinese Customs when they go through customs clearance, according to this announcement made by the Chinese Commerce Ministry, Chinese Customs, and China National Medical Product Administration (NMPA):

April 1st China moves to ensure quality of medical supply exports

This new exporter furnished declaration to the Chinese Customs should include the following information/proof:

The Chinese exporter is qualified to exporting the said products.
Products in the shipment are registered in proper medical device categories with NMPA, China’s counterpart to the US FDA.
List and meet quality-control product standards of of the exporting.

Now Chinese Customs will only release export shipments with the said medical device categories with proper certificates of registration approved by NMPA, according to the notice jointly issued with the General Administration of Customs and the National Medical Products Administration.

IMPACT TO OVERSEAS IMPORTERS & BUYERS

Overseas importers and buyers, when sourcing PPEs and other devices in China, now must check and ensure that (1) the local supplier is qualified to export their products, (2) sourced products have property resisted with Chinese authorities in the correct medical device category, and (3) these products meet all destination country’s quality, regulation, and import standards.

GreenPPE believes this executive order from China is a right step towards ensuring authenticity and quality of PPE and other devices they produce. We are helping overseas buyers/importers to these medical devices produced in China with both China export standards and destination country’s import standards.

Sourcing PPE products from China? Check how many domestic manufacturers that are actually approved by the Chinese authorities to export. Contact the GreenPPE team and let us help vet your sources.

Can I Import KN95 Respirators from China to US for Medical Care Use?

Posted on April 1, 2020April 4, 2020 by Lee Wang

Starting from April 3 2020, the quick answer is “YES” but with certain conditions.

The US FDA has just officially announced that it will allow China-made KN95 to be used in the US during the COVID-19 pandemic outbreak in healthcare settings. Essentially, non-NIOSH-approved respirators that have obtained China’s KN95 certification are eligible to apply for a new FDA authorization before they can be imported to the US and used by healthcare personnel (HCP) in the US, provided certain quality criteria are met.

IS MY KN95 QUALIFIED FOR THIS AUTHORIZATION?

Your KN95 is now eligible to apply for this authorization for the US market, if you can demonstrate to the FDA some additional quality proof of your respirator, in addition to your KN95 certification:

The same manufacturer of your KN95 has US NIOSH-approvals for FFR models;
Your KN95 has obtained a NIOSH N95-equivalent certification outside China that FDA recognizes; Or
Your KN95 comes with a test report issued by an FDA-recognized independent test lab.

In essence, FDA is saying that beyond your KN95 certification issued by China, you need to provide another quality proof that your KN95 really meets US NIOSH N95 or standard or another one that is N95 equivalent.

HOW TO APPLY FOR THIS AUTHORIZATION?

Here is the workflow for KN95 manufacturers to obtain needed FDA authorization before importing their products to the US, during the period of the COVID-19 outbreak:

GreenPPE KN95 Pathway

This KN95 US authorization contains two phases

PRE-MARKET: Choose one of the three proof criteria path established by the FDA. Prepare and collect all needed documents, certifications, quality proof. Create an FDA application and submit all required information. Respond, follow up and interact with FDA in English during the application process towards obtaining a timely authorization.
POST-MARKET: KN95 manufacturers must meet all post-market requirements in order to market their products in the US, including but not limited to
1. Publish and maintain an English website for your KN95 and other products marketable in the US, using FDA-approved verbiage for the intended use, fit testing, and other product information and instructions.
2. Produce and distribute a letter in English for US end-user facilities containing FDA-required information.
3. Establish and manage a process for reporting adverse events in the US of which they become aware and send regulated reports to the US FDA. You must keep the the communications channel open with FDA.
4. Only use regulated language for your KN95 with no false advertising. All descriptive material relating to the product itself and the use of it in the US must be consistent with applicable CDC recommendations during
  the COVID-19 outbreak. None of them may represent or suggest that the product is safe or effective for the prevention of COVID-19.

It is important to take notice that FDA will remove our your KN95 US authorization, if any of the post-market requirements are not met, or if you lost communications with FDA.

HOW SOON CAN I IMPORT MY KN95 TO US?

During the COVID-19 pandemic, once FDA authorizes your KN95, you can immediately import and distribute your product to US healthcare personnel (HCP) in healthcare settings.

WHY WORK WITH GREENPPE?

Located in the US and working as their extended team, our FDA experts are helping overseas KN95 manufacturers and suppliers review, submit, follow up and interact with FDA for a timely US authorization during the COVID-19 outbreak. In addition, GreenPPE provides all-inclusive support that covers FDA-mandated post-market items for the US market, including but not limited to: creating and managing a product English website, creating and distributing the US end-user letter, reviewing product label and other product information in English against FDA and CDC standards, and checking and removal of false advertising.

Once your KN95 is authorized by the FDA, GreePPE can also directly link you with volume buyers from both public and private sectors US. We do this to help fight the COVID-19 outbreak.

We’d like to do our part by sending you a free estimate about the qualification of your KN95 for this FDA authorization for the US market. This is now the only road block between your KN95s and the US market.