Are you considering importing PPE or other Medical Equipment into the United States?
The impact of COVID-19 has created an unprecedented global demand for medical equipment needed to combat and treat the virus.The critical nature of PPE and other medical supplies has created a crisis of supply and demand for hospitals, state and local authorities and private individuals. In response, many US companies are considering importing medical and non-medical equipment to meet this demand. Governmental agencies in the US and abroad have been forced to respond to the COVID-19 pandemic with new and updated regulation regarding the import of critical supplies. We offer the following information as a reference for importers who are interested in importing PPE or other medical equipment into the United States.
What is PPE and what are the different types?
This helpful link from the FDA contains general information including definitions of PPE. The FDA refers to PPE as "protective clothing, helmets, gloves, face shields, goggles, surgical masks, respirators, and other equipment designed to protect the wearer from injury or help prevent wearer exposure to infection or illness." For purposes of import, PPE is classified by the FDA as medical or non-medical depending on how the products will be used. The guidelines and requirements vary depending on whether the product is classified as medical or non-medical.
China has implemented new requirements related to the export of medical and non-medical items.
The Chinese Ministry of Commerce (MOFCOM) has announced effective April 26, manufacturers exporting non-medical face masks must submit a declaration, jointly signed by the importer and exporter in either written or electronic format, stating the products meet the qualification standards of either China or the importing country. The declaration must also state the foreign importer is aware that the face masks are not to be used for medical purposes.
In addition, effective April 26, MOFCOM is also requiring exporters to submit a written declaration that all products such as COVID-19 inspection reagents, medical gowns, thermometers, ventilators, medical surgical caps, medical goggles, medical gloves, medical shoe covers, ICU monitors, medical face masks, PPE, respirators and infrared thermometers meet the qualification and safety standards of the importing country.
A sample Joint Declaration of the Exporter and Importer form mentioned above can be found HERE.
The following is a list of Chinese Customs Regulation currently in effect for the export of medical product from China.
- The China shipper must provide an 18-digit Code of Customs Clearance Form of Export Commodity for customs clearance. This code is required for each shipment.
- In order to receive the 18-digit Code, the Chinese manufacture must apply to China local customs for their product's export commodity inspection (CIQ).
- If the China shipper and the manufacturer names are not the same, a contract is required.
- Application process usually takes 2-3 working days. However, due to the volume of applications, it could take up to seven days for the Code to be issued.
- Application process can be completed while the product is still in production with the manufacturer.
- Products designated as non-medical are exempt from this process.
Food and Drug Administration - and its role in importing PPE
Medical Emergency Use Authorizations.
The FDA has issued emergency use authorizations (EUA) to facilitate the import, entry, and use of disposable filtering facepiece respirators, ventilators and diagnostic testing kits. The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, or nuclear (CBRN) threats by facilitating the availability and use of Medical Counter Measures (MCMs) needed during public health emergencies.
The Food and Drug Administration (FDA) website contains information for US Importers of PPE and Medical equipment on providing entry information during COVID-19. The procedures for importing products regulated by the FDA differ, depending on the product type. We have listed the three options below as defined by CSMS #42448725.
1. Non-FDA-regulated general purpose personal protective equipment (masks, respirators, gloves, etc.)
Personal protective equipment for general purpose or industrial use (that is, products that are not intended for use to prevent disease or illness) is not regulated by FDA.
For these types of products, entry information should not be transmitted to FDA. At the time of entry for these products, Importers should transmit entry information to US Customs and Border Protection (CBP) using an appropriate HTS code with no FD Flag; or using an appropriate HTS code with an FD1 flag and do a ‘disclaim’ for FDA.
2. Importing products authorized under an EUA
When importing such products, entry information should be submitted to FDA; however reduced FDA information is required for review.
At the time of entry, Importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use Device, and an appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE.
Below is a list of products and the appropriate product codes that are currently authorized by an EUA:
- Diagnostic tests: 83QKP, 83QKO, 83QJR
- Masks/Respirators: 80NZJ
- Ventilators: See ventilator EUA for product codes
A full list of Emergency Use Authorizations currently in place for the COVID-19 emergency is also available on FDA’s website. Please check this site regularly for current information on products authorized by an EUA.
3. Importing products regulated by the FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance
When importing such devices, entry information should be submitted to FDA.
At the time of entry, Importers should transmit Intended Use Code 081.006: Enforcement discretion per final guidance, and an appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE.
Additional CSMS announcements related to COVID-19 for your reference:
FEMA Export Prohibitions
There have been actions taken regarding the export of PPE and other medical equipment. On April 3, 2020, President Trump signed a Memorandum on Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use. This rule is effective from April 7, 2020 until August 10, 2020.
The Federal Emergency Management Agency (FEMA) issued a temporary rule to allocate certain scarce or threatened materials for domestic use. These materials may not be exported from the United States without explicit approval by FEMA. The rule covers five types of personal protective equipment (PPE).
An excerpt from the rule as posted in the Federal Register:
"In furtherance of such policy, the President directed that the Secretary of Homeland Security, through the FEMA Administrator, and in consultation with the Secretary of HHS, shall use any and all authority available under section 101 of the Act to allocate to domestic use, as appropriate, the following scarce or threatened materials designated by the Secretary of HHS under Section 102 of the DPA:
- N95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;
- Other Filtering Facepiece Respirators (e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100), including single-use, disposable half-mask respiratory protective devices that cover the user's airway (nose and mouth) and offer protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181;
- Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;
- PPE surgical masks, including masks that cover the user's nose and mouth and provide a physical barrier to fluids and particulate materials; and
PPE gloves or surgical gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such gloves intended for the same purposes."
Operational Issues you should know about and actions we recommend
- Be advised that a 'dead freight fee' will result if, for any reason, the export shipment shipment does not pass exam by the Chinese customs authorities government and the shipment is detained in China. This could occur for any number of reasons (bogus supplier, counterfeit goods, improper packaging, etc). In this case, the US Importer is still liable for the air freight charges and potential additional fees (warehousing, etc).
- It is important to know your shipper! The market for import of PPE into the United States is changing rapidly. The FDA, CBP and the Chinese government have all issued new or updated regulations. The temptation for unscrupulous suppliers to profit from this high-demand means you must take care to know your supplier. Are they duly licensed and certificated at origin? Are they lawful to manufacture, distribute and actually export these product? Remember, as we mention above, China is requiring certain PPE goods meet the certification standards of the importing country.
Our Recommended Actions:
US Importers and exporters are strongly recommended to communicate closely with their suppliers to forecast production capability. This will provide you with the most realistic timeline to fill orders.
Make your bookings well in advance to secure space and rates. The fluid nature of this situation makes it difficult to give refined predictions regarding space and costs.
- In addition to close communication with your suppliers, we encourage that you keep your sales or customer service representative up-to-date on your supply chain needs. This will allow us to engage with carriers and overseas offices to better assist you during this unprecedented event.
CBP has created an online portal for questions. https://imports.cbp.gov/s/
FDA information on product classification. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2697
FDA Devide Registration and Listing https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
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