The supplier will have to undergo NIOSH certification which costs about $8,000 per year and includes annual factory assessments by NIOSH inspectors. The certification process is very strict, which is why NIOSH-certified products are usually only acceptable for healthcare usage, as they are proven to provide a high and trusted standard.
Here are some quick NIOSH certification knowledge points:
- Each mask production facility must hold its own certification.
- Each model of mask requires a separate certification (as some factories may make more than one type).
- Typical lead time from when a mask certification application is submitted to when it is approved is 6 months (any changes to any aspect of the product will require another 6 month lead time for re-certification).
- An on-site testing lab will need to be put in place.
In the long-term a NIOSH-certified factory also needs to become FDA-certified, too, in order to export to the USA. They will notify the FDA of their intent to market medical devices by submitting a 510 (k) clearance.
Surgical masks
Yes, the FDA will not object to surgical masks may be imported, distributed, and used during the coronavirus pandemic without compliance with the following regulatory requirements where the surgical mask does not create an undue risk in light of the public health emergency:
- Prior submission of a premarket notification under section 510(k) of the FD&C Act and
21 CFR 807.81, - Registration and Listing requirements in 21 CFR 807,
- Quality System Regulation requirements in 21 CFR 820,
- reports or corrections and removals in 21 CFR Part 806,
- Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20.
Respirators
Yes, the insistence on adherence to the NIOSH performance standard has been temporarily relaxed during the coronavirus pandemic, and importers are able to bring in correctly-certified Chinese ‘KN95’ standard FFR respirators (and those from other countries) during this time.
The CDC has released a list of Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China.
The FDA states:
“As part of a set of crisis management recommendations,
the FDA identifies alternatives to FDA-cleared or NIOSH-approved N95 respirators approved under standards used in other countries, some of which were evaluated under methods that are similar to NIOSH-approved N95 respirators. For the duration of the public health emergency, when FDA cleared or NIOSH-approved N95 respirators are not available, FDA does not intend to object to the distribution (including importation) and use of respirators identified in the CDC recommendations without compliance with the following regulatory requirements:
the FDA identifies alternatives to FDA-cleared or NIOSH-approved N95 respirators approved under standards used in other countries, some of which were evaluated under methods that are similar to NIOSH-approved N95 respirators. For the duration of the public health emergency, when FDA cleared or NIOSH-approved N95 respirators are not available, FDA does not intend to object to the distribution (including importation) and use of respirators identified in the CDC recommendations without compliance with the following regulatory requirements:
- Prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,
- Registration and Listing requirements in 21 CFR 807,
- Quality System Regulation requirements in 21 CFR 820,
- Reports of corrections and removals in 21 CFR Part 806, and
- Unique Device Identification requirements in 21CFR Part 830 and 21 CFR 801.20.
Because FDA cannot confirm the authenticity of the respirators described above, FDA recommends that importers take appropriate steps to verify the authenticity of the products they import.”
Despite the FDA’s EUA (Emergency Use Authorization) allowing the importation of non-NIOSH approved respirators, there are still certain requirements in place:
- The KN95 FFR must either:
- Be manufactured by an entity which holds a NIOSH certification for other model/s.
- Have regulatory approval from a non-Chinese entity which is FDA-verified.
- Or have documented testing reports that the FDA can peruse and verify.
- The FDA must be supplied with a review of the product by the manufacturer which they then approve.
- Manufacturers are expected to publish intended use information, notify users and importers about any changes, and provide the FDA with reports.
- Importers must ensure that the KN95 FFRs meet CDC/FDA requirements and must clearly state that they do notsuggest that the product is ‘safe or effective’ at stopping covid19.
This summary comes from an FDA letter regarding importation of KN95 FFRs to the USA dated 4/3/20- read it in full here.
Yes, they have, and this will affect importing face masks from China to the USA.
In response to a market which was getting out of control, on 4/1/20 China increased restrictions on who is allowed to export PPE (free registration to read articles) and has created an official list of authorized medical goods exporters. This may restrict availability, but will help to ensure better-quality products are exported following various high-profile cases of defective PPE being shipped overseas from China.
Here is a summary of the government’s order (courtesy of China Law Blog and you may read the full official Chinese government page here):
The title is Order Concerning the Orderly Export of Medical Supplies 关于有序开展医疗物资出口的公告.
The Order was issued effective April 1, 2020 jointly by the Ministry of Commerce, the Customs Bureau and the National Medical Products Administration. The Order is temporary and can be expanded or revoked at any time. The text of the Order and its supplementary exhibits can be found here (in Chinese only).
The Order applies to the export of the following medical supplies:
- Novel Coronavirus Test Kits 新型冠状病毒检测试剂.
- Medical Use Face Masks 医用口罩.
- Medical Use Protective Clothing 医用防护服.
- Ventilators 呼吸机.
- Infrared External Thermometers 红外体温计.
For the listed products, the exporter must meet two requirements. First, the product or device must be registered in China having obtained a PRC Medical Device Product Registration Certificate. The exporter must provide the registration number for the product/device as a requirement for export. As an exhibit to the Order, a spreadsheet is provided that lists all entities that have obtained this required certification. For many products, the number of certified companies is very small. Second, the product or device must comply with the quality standards of the importing country. How this proof is to be provided is not stated.
The Chinese exporter is required to submit a signed form to China customs stating the required information and affirming its accuracy. A copy of this form is included as an exhibit to the Order. Exporting under an inaccurate or falsified statement subjects the exporter to liability under Chinese law.
If you’re buying from a Chinese supplier, they are responsible for fulfilling the government’s requirements, but you as the buyer also need to take responsibility for checking that they do because these days we’ve seen that most suppliers are requesting payment up front for the goods.
Imagine the scenario where you have paid in full for an order of PPE, only then to find out that the supplier is prohibited from exporting the goods to your country? It is not guaranteed that you would be given a refund!
We have recently checked with local testing labs in China (as of 4/7/20) and they are quoting up to 10 months lead time to perform tests. Even for a single test, for example a BEF test for surgical masks, the lead time is one month. This should be borne in mind by importers seeking to check their products.
Yes, you can use the FDA’s website here. Just input as much of the supplier’s company information that you know as possible.
Also, remember to check the scope of the supplier, as this will show you whether they actually provide the types of masks that you are trying to import.
You can check an alphabetical list of NIOSH-approved respirator manufacturers on the CDC’s website here.
The laboratory tests for Chinese standards should be performed by a lab that is listed in this directory and is authorized for this kind of product.
As shown on this page, the FDA has many regulations for surgical masks and respirators that are meant to be used for medical purposes.
To circumvent the time it takes to become properly certified for export to the USA or EU, many Chinese companies are exploiting a loophole where FDA regulations are fewer for non-surgical PPE. (Source: FT – paywall) These masks often look the same as their ‘for medical use’ cousins, which is part of the problem.
While these items may provide some kind of protection, they likely do not meet the strict pharmaceutical testing criteria which provide the best protection against infection applied to items for medical use. Therefore it is prudent to check the item’s product code to confirm the mask type via the FDA product classification online database.
Even if you can’t run new lab tests, you can focus on paperwork, auditing, and inspections to reduce risks:
- Due diligence on suppliersbefore placing orders – are they legitimate manufacturers, are they legal?
- Certificate verification– is their CE certificate real? Are the documents they provide for the correct products?
- Factory audits– this may be more effective if you are placing very large orders (millions of pieces), but they will allow you to know that the factory is capable of producing the products you need at the right standards.
- Product inspections– gives you the security that your products are good quality before they are shipped.
Yes, you do. You can register here.
Planning on importing face masks to the USA, but unsure about it, or need help?
We’re helping clients globally undertake due diligence on PPE suppliers, inspecting products before shipping, and much more. If you’re stuck, perhaps we can help!
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