These days, it seems everybody has jumped on the same ‘PPE’ bandwagon.
In China, hundreds (maybe thousands) of manufacturers have seized this opportunity. Many of them have zero experience in the medical field, or in any regulated industry for that matter.
And, all over the world, buyers are looking for personal protective equipment (PPE) and related medical products. Again, a minority of them have a full understanding of the implications of what they are getting into.
A lot of products shipped without the necessary evidence, a lot of product that is blocked and can’t be exported out of China, or many imported products that are found to be non-conforming and go directly to the trash, and, potentially, more people who get infected!!
We have responded to many questions and requests from our clients about what is required, and we decided it was time to document it all in an easy-to-consume manner. Starting with face masks — both a high-demand and high-risk item.
For importing masks into the USA
We prepared a general set of guidelines for importing face masks into the USA. Hopefully, this helps answer most of the questions you may have. We included many links to the source documents, so you can go more in-depth into this topic.
We are also going to try and clarify what is ‘normal policy’ and what ‘temporary exemptions’ as per the recent “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19)” publication by the US FDA.
As a quick summary, the usual regulations have been temporarily suspended for face mask and respirator imports to the USA:
The FDA will not object to surgical masks and respirators being imported, distributed, and used during the coronavirus pandemic without compliance with the following regulatory requirements where the 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 and21 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.
Regarding medical respirators, the FDA provides a helpful page here regarding their Non-NIOSH Approved Respirator EUA (Exceptional Use Authorization) showing that foreign respirators, such as China’s KN95 certified respirators, can be temporarily imported if they conform to local standards.
The FDA states:
“Other countries approve respirators according to standards. These devices are evaluated using methods similar to those used by NIOSH, and are still expected to provide adequate protection for healthcare personnel, given shortages of FFRs resulting from the COVID-19 pandemic. Under these circumstances, FDA believes these devices may serve as suitable alternatives for personal respiratory protection during this period of shortage caused by the COVID-19 pandemic.”
For importing PPE and related medical devices into the European Union
We are still compiling all the data about the EU’s requirements. It is not an easy task, even for someone used to regulatory standards.
We can already share a very useful flow chart our analyst has prepared about the most basic thing to keep in mind:
- What is considered a “medical device”
- What is considered “personal protective equipment”
And what the implications are.
For exporting PPE and related medical devices out of China
Since April 1st, China’s Customs check every shipment of medical masks, protective suits, infrared thermometers, etc. and does not hesitate in blocking a batch. You can read the Chinese government’s ‘Order Concerning the Orderly Export of Medical Supplies’ here (link in Chinese, translate the page).
China Law Blog translated it here, and it states:
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.
They want the products to be properly labeled, and to come with a proof of compliance — not only versus the importing country’s standards & regulations but also versus China’s own standards & regulations.
And this has been a moving target!
Things changed this morning, and as I write this:
- Chinese Customs don’t accept any declaration that KN95 are civilian-grade. They are all to be declared as medical grade. Same thing for N95 FFP2 and FFP3 (which is an FDA medical standard) and for 3-ply masks.
- Chinese Customs have to go to the factory for an inspection before authorizing the shipment, for all medical devices (not just masks). They may run a lab test in the factory’s internal lab.
- This will definitely decrease the number of export-ready factories.
This decision might get reversed anytime. But that gives you an idea of the risk involved. Buyers are required to send payments upfront, so they might get stuck with a batch they paid for but they can’t get out of China… As I wrote before, buying masks is inherently risky these days.
Once all this is clear…
All these considerations are the foundation for any verification of certicates, lab test reports, registrations, and other documents that are provided by manufacturers and are supposed to demonstrate that the products can safely be imported.
Only once it is all clear, can someone do a good job of verifying those documents and giving an informed answer.
Here are some of the points our team checks by default, to give you an idea of the nature of the work:
- What is this document?
- When was it issued?
- When was the testing done?
- What does it cover?
- What standard does it mention?
- What type of standard is it?
- Is it a medical standard?
- What organization issued it? (Name)
- What organization issued it? (Address)
- What type of organization is it?
- What is their accreditation body?
- Is this organization accredited to do such tests on such products?
- If it is a certificate: do we also have the corresponding laboratory test results?
- Is there anything in the test results that seems off or unusual?
- Can we verify the legitimacy of this document with the issuing organization?