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): 

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

1. The Chinese exporter is qualified to exporting the said products.
2. Products in the shipment are registered in proper medical device categories with NMPA, China’s counterpart to the US FDA.
3. 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.

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:

1. The same manufacturer of your KN95 has US NIOSH-approvals for FFR models;
2. Your KN95 has obtained a NIOSH N95-equivalent certification outside China that FDA recognizes; Or
3. 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:

This KN95 US authorization contains two phases

1. 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. 
2. 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. 

In March 2020, the US Secretary of Health declared that circumstances exist justifying the authorization of emergency use of certain personal protective equipment (PPE) during the COVID-19 outbreak, subject to the terms of any authorization issued under that section.

The Emergency Use Authorization allows FDA to help strengthen the nation’s public health protections against certain threats by facilitating the availability and use of resources needed during public health emergencies. As the result, FDA has established an expedited approval process for certain PPE products for overseas manufacturers and suppliers.  

Compared to the months of time with the regular FDA PPE approval process, now we can send your PPE products through the expedited approval process, specially established by the FDA during the US COVID-19 outbreak time. Each case is different but we have helped overseas PPE manufacturers and suppliers obtain the FDA approval for US entry within a week.

With the new FDA PPE COVID-19 process, your N95-equivalent respirator product produced outside of the US does not need to be N95 certified by the NIOSH. Instead, you can applying now for an FDA emergency authorization to enter the US market, provided your product meets N95-equivalent product standard in Australia, Brazil, EU, Japan, Korea, or Mexico. 

For China-made KN95 respirators, you should apply for the same FDA authorization if your product already has the CE marking for the EU market. Check here for more information. 

To take advantage of FDA’s expedited approval process during the COVID-19 outbreak, you should check whether

• Your product meets certain non-US standards such as EU’s (CE Marked) that FDA deems equivalent to its own standards
• You have English product labeling that meets FDA requirements.
• You have a English website and posted FDA-required product information
• You have prepared a product information letter to US end-user facilities
• You have a contact in place for product support and FDA inquiries

Doesn’t have all of them or not sure? Don’t worry – GreenPPE team is ready to help. Our US-based FDA experts are getting the much-needed FDA authorization and required post-market support for overseas PPE manufacturers and suppliers. Each case is different – you could get the FDA authorization pretty quickly within several days.  

Fill this simple form and let us send you within 24 hours a free confidential US market readiness report for your PPE product. 

Please contact us to get specific information for your PPE products. As an example, if your disposable filtering facepiece respirators (FFRs) are already CE marked for EU PFF2 or PPF3 product classifications, you are qualified to apply for an expedited approval with FDA.