Importing PPE and EUA Goods
Learn what importers need to know when importing personal protective equipment (PPE), medical devices, and other goods subject to Emergency Use Authorization (EUA) requirements.
What Do You Need to Know?
Import requirements for PPE, medical devices, diagnostic tests, and other EUA-related goods depend on the product, its intended use, classification, and country of import.
This guide covers key Canada and U.S. requirements, including tariff classification, customs procedures, and applicable Health Canada and FDA regulations. Many COVID-19 measures have expired, including Canada’s COVID-19 duty relief, which ended May 7, 2022. FDA’s COVID-19 EUA declarations for certain devices are scheduled to be terminated on December 26, 2026.
HS Classification and Tariff Resources
The World Customs Organization (WCO) and World Health Organization (WHO) published an indicative HS classification reference for COVID-19 medical supplies during the pandemic. For current classification, refer to the applicable customs tariff and classification rules. For Canada, use the 2026 Canadian Customs Tariff. For the United States, use the current Harmonized Tariff Schedule of the United States (HTSUS).z
Canada PPE/EUA (Health Canada)
Canada’s temporary customs duty relief under the Certain Goods Remission Order (COVID-19) ended on May 7, 2022. The relief applied to eligible goods imported during the period covered by the Order.
See the CBSA’s Customs Notice 22-08 for details on the end of the relief.
Canada provided temporary customs duty relief for certain medical goods, including PPE such as masks and gloves, during the COVID-19 pandemic. The relief ended on May 7, 2022.
The special authorization code 20-304 and the related duty-relief procedures are therefore not applicable to current imports. For current duty treatment, consult the 2026 Canadian Customs Tariff.
The Goods for Emergency Use Remission Order provided temporary customs duty and tax relief for certain goods imported for emergency use during the COVID-19 pandemic. The related relief under Tariff Item 9993.00.00 ended on May 7, 2022, when the temporary COVID-19 measures expired.
The former special authorization procedures, including identifying shipments as “URGENT – COVID-19,” were part of those temporary measures and do not apply to current imports. For current imports, determine the applicable tariff classification and duty treatment under the 2026 Canadian Customs Tariff.
See CBSA Customs Notice 22-09 for the details of the expired measures.
Health Canada regulates medical masks and respirators as Class I medical devices when they are sold or represented for a medical purpose.
- Medical masks and respirators: Class I medical devices
- Medical Device Licence (MDL): Not required for Class I devices
- Medical Device Establishment Licence (MDEL): Generally required for manufacturers, importers and distributors of Class I medical masks and respirators, subject to applicable exemptions
- Non-medical masks and barrier face coverings: Generally not medical devices unless they make medical claims or representations
For current requirements, see Health Canada’s Medical masks and respirators guidance.
Medical gowns and gloves may be regulated as medical devices depending on their intended use and claims.
Medical gloves
- Medical gloves are Class II medical devices
- The manufacturer must have a valid Medical Device Licence (MDL) for the device
- Importers and distributors generally require an MDEL, subject to applicable exemptions
See Health Canada’s medical device licensing information for current requirements.
Medical gowns
Medical gowns may be regulated as medical devices depending on their intended use and claims. Importers should confirm the applicable classification and licensing requirements before importing.
Alcohol-based hand sanitizers containing ethanol or isopropanol as a single medicinal ingredient are regulated as natural health products (NHPs) in Canada and require a Natural Product Number (NPN) to be legally sold or distributed.
Commercial importers must also meet applicable import and site-licensing requirements. See Health Canada’s hand sanitizer requirements.
The WCO and WHO published an indicative COVID-19 medical supplies classification reference in 2020 using the HS 2017 nomenclature. For current classification, importers should use the 2026 Canadian Customs Tariff and applicable Canadian classification rules.
Duty Relief on Non-Medical PPE to Support Front Line Workers of Essential Services
Canada introduced temporary measures during the COVID-19 pandemic to support access to certain non-medical PPE for essential workers. These temporary measures are no longer applicable.
For current duty treatment, consult the applicable classification and tariff treatment in the 2026 Canadian Customs Tariff.
During the COVID-19 pandemic, I.E. Canada requested conditional customs duty relief on certain non-medical personal protective equipment (PPE) to help essential businesses obtain protective equipment that was not readily available from domestic suppliers. The request noted that some non-medical PPE products were subject to customs duty rates of up to 18%.
This was a COVID-19-era request and did not establish a permanent duty-relief measure. The temporary COVID-19 customs duty relief administered by the CBSA expired on May 7, 2022. For current imports, importers should determine the applicable tariff classification and duty treatment under the 2026 Canadian Customs Tariff.
USA PPE/EUA (FDA)
In 2020, Chairman Richard Neal (D-MA) requested a 90-day suspension of tariffs on certain PPE and other products used in the COVID-19 response. The request was a COVID-19-era proposal and did not establish a permanent suspension of U.S. customs duties.
For current imports, duty treatment depends on the applicable Harmonized Tariff Schedule of the United States (HTSUS), country of origin, and any additional tariff measures that apply to the product. Importers should use the current HTS rather than relying on the tariff information in the original COVID-19 request.
See the current U.S. Harmonized Tariff Schedule for applicable tariff classifications and duty rates.
The FDA may issue an Emergency Use Authorization (EUA) for certain unapproved medical products or unapproved uses of approved products when the applicable statutory criteria are met during an emergency.
For COVID-19-related medical devices, including certain PPE and in vitro diagnostic devices, the HHS declarations supporting the EUAs are scheduled to terminate on December 26, 2026. On that date, COVID-19 EUAs for medical devices currently listed by FDA will no longer be in effect.
See the FDA’s Emergency Use Authorization page and COVID-19 Emergency Use Authorizations for Medical Devices for current information and product-specific authorizations.
For medical devices that have a COVID-19 EUA before the applicable EUA declaration terminates, FDA states that filers should use Intended Use Code (IUC) 940.000: Compassionate Use/Emergency Use Device with the appropriate FDA product code.
After the relevant EUA declaration terminates, FDA states that filers should use IUC 081.001: Standard import of a device, with the appropriate FDA product code. Applicable registration, listing, and premarket approval or clearance information can be submitted in ACE when required.
See FDA’s Importing Medical Devices Relating to COVID-19 guidance for current import procedures.
FDA regulates face masks and respirators when they meet the definition of a medical device, including when they are intended for a medical purpose.
COVID-19-related PPE EUAs remain in effect until the applicable medical-device EUA declaration terminates on December 26, 2026. After that date, products previously imported under a COVID-19 EUA must meet the FDA requirements applicable to their specific device and intended use.
For current requirements and product-specific information, see FDA’s Personal Protective Equipment EUAs page.
Gowns, other apparel, and gloves may be regulated by FDA when they are intended for a medical purpose. Requirements depend on the specific product, intended use, classification, and applicable FDA authorization or marketing requirements.
COVID-19-era enforcement policies should not be used as a current general import pathway. FDA states that the enforcement-policy guidances covered by its transition plan are no longer in effect.
For products that were imported under a COVID-19 EUA, the applicable EUA remains in effect until December 26, 2026, unless otherwise terminated earlier. Importers should review the applicable FDA authorization and current import requirements before entry.
Ventilators, respiratory devices, and accessories may be regulated as medical devices by FDA. COVID-19-related EUAs for medical devices are scheduled to terminate on December 26, 2026.
Before the applicable EUA declaration terminates, FDA states that filers may use IUC 940.000: Compassionate Use/Emergency Use Device for devices issued an EUA. After termination, FDA states that the appropriate entry procedure is IUC 081.001: Standard import of a device, with the applicable FDA product code and other required information.
Non-invasive remote monitoring devices may be regulated as medical devices depending on their intended use and characteristics.
The COVID-19 enforcement policy that supported certain remote monitoring devices during the public health emergency is no longer a current general import pathway. Importers should determine the device’s current FDA classification, authorization or marketing status, and applicable import requirements.
FDA has issued EUAs for certain in vitro diagnostic tests for SARS-CoV-2. The HHS declaration supporting COVID-19 EUAs for in vitro diagnostics is scheduled to terminate on December 26, 2026. COVID-19 EUAs for devices currently listed by FDA will no longer be in effect after that date.
For a COVID-19 diagnostic device currently imported under an EUA, FDA states that filers may use IUC 940.000: Compassionate Use/Emergency Use Device with the appropriate product code. FDA also recommends providing a signed copy of the applicable EUA Letter of Authorization with the import entry documentation.
Importers should review FDA’s current COVID-19 Emergency Use Authorizations for Medical Devices page for current authorizations and transition information.
The FDA regulates several types of sterilizers as medical devices. The applicable classification depends on the device type, intended use, and product code.
Classification – Device Type – Product Code – Class
- 21 CFR 872.6730 – Sterilizer, endodontic dry heat – KOK – Class III
- 21 CFR 872.6730 – Sterilizer, glass bead – ECC – Class III
- 21 CFR 880.6100 – Cabinet, ethylene oxide gas aerator – FLI – Class II
- 21 CFR 880.6860 – Sterilizer, chemical – MLR – Class II
- 21 CFR 880.6860 – Two or more sterilant sterilizer – PJJ – Class II
- 21 CFR 880.6860 – Sterilizer, ethylene oxide gas – FLF – Class II
- 21 CFR 880.6870 – Sterilizer, dry heat – KMH – Class II
- 21 CFR 880.6880 – Sterilizer, steam – FLE – Class II
- 21 CFR 880.6880 – Sterilizer automated loading system – PEC – Class II
The FDA Product Code Classification Database lists KOK and ECC under 21 CFR 872.6730 as Class III devices.
The FDA lists FLI under 21 CFR 880.6100 as a Class II ethylene oxide gas aerator cabinet. It also lists FLF, MLR, and PJJ under 21 CFR 880.6860, KMH under 21 CFR 880.6870, and FLE and PEC under 21 CFR 880.6880, all as Class II devices.
For purposes of this guidance, FDA-regulated chemical and physical disinfectant devices include devices used to clean, disinfect, or sterilize medical devices. These include medical washer-disinfectors, automated endoscope reprocessors, and devices that use chemical or physical processes for reprocessing.
FDA Regulated
Chemical/Physical Disinfectant Devices
Classification – Device Type – Product Code – Class
- 21 CFR 876.1500 – Accessories, cleaning, for endoscope – FEB – Class II
- 21 CFR 880.6885 – Sterilant, medical devices – MED – Class II
- 21 CFR 880.6885 – Solution, cold sterilizing – LFE – Class II
- 21 CFR 880.6992 – Device disinfector, medical devices – MEC – Class II
- 21 CFR 880.6992 – Device cleaners, medical devices – MDZ – Class II
- 21 CFR 892.1570 – High level disinfection reprocessing instrument for ultrasonic transducers, mist – OUJ – Class II
- 21 CFR 892.1570 – High level disinfection reprocessing instrument for ultrasonic transducers, liquid – PSW – Class II
The FDA currently lists FEB, MED, LFE, MEC, MDZ, OUJ, and PSW as Class II devices under the regulations above. The FDA classification database identifies MEC as a medical washer-disinfector and MDZ as a medical device cleaner.
Ultraviolet (UV) Disinfecting Devices
UV disinfecting devices use ultraviolet radiation to reduce or eliminate microorganisms. FDA classification depends on the device’s intended use and technology.
The FDA lists ultraviolet (UV) radiation chamber disinfection devices under 21 CFR 880.6600, product code OSZ, Class II. The current FDA database describes OSZ as a device intended to reduce microbial populations using germicidal ultraviolet light.
Other UV-related devices have separate FDA classifications, including:
- 21 CFR 880.6510 – Whole room microbial reduction device – QXJ – Class II
- 21 CFR 880.6511 – Ultraviolet radiation disinfection chamber device – SCS – Class II
- 21 CFR 880.6512 – Ultraviolet light-based microbial reduction device for luer-activated valves – SGX – Class II
- 21 CFR 880.6600 – Ultraviolet (UV) radiation chamber disinfection device – OSZ – Class II
- 21 CFR 880.6500 – Medical ultraviolet air purifier – FRA/MKB – Class II
- 21 CFR 880.6710 – Medical ultraviolet water purifier – KMG – Class II
The FDA’s current classification database lists these UV-related devices as Class II.
Medical air purifying devices include devices intended to filter or otherwise reduce airborne particles or microorganisms for medical purposes. FDA classification depends on the device’s intended use and the technology it uses, such as filtration or ultraviolet radiation.
FDA-Regulated Air Purifiers
Classification – Device Type – Product Code – Class
- 21 CFR 880.5045 – Medical recirculating air cleaner – FRF – Class II
- 21 CFR 880.6500 – Medical UV air purifier – FRA – Class II
The FDA classifies medical recirculating air cleaners under 21 CFR 880.5045, product code FRF, as Class II devices. These devices can use filtration to remove or reduce airborne particles for medical purposes.
The FDA also classifies medical UV air purifiers under 21 CFR 880.6500, product code FRA, as Class II devices. These devices use ultraviolet radiation to reduce or inactivate microorganisms in the air.
FDA regulates clinical electronic thermometers as Class II medical devices under 21 CFR 880.2910. The classification and premarket requirements depend on the thermometer’s intended function and product code.
FLL – Continuous Measurement Thermometers
The FDA classifies continuous measurement thermometers under 21 CFR 880.2910, product code FLL, as Class II devices. These devices measure a person’s body or skin temperature continuously or at specified intervals and can use contact or non-contact methods. The devices may transmit temperature readings to a compatible monitor or other device.
FLL devices remain subject to 510(k) premarket notification. Manufacturers must obtain FDA clearance before marketing applicable devices in the United States and comply with applicable postmarket requirements.
SDV – Clinical Electronic Thermometers
FDA also lists clinical electronic thermometers under product code SDV as Class II devices under 21 CFR 880.2910. SDV covers thermometers that intermittently measure body temperature and do not have telethermography or continuous temperature measurement functions. FDA exempts these devices from 510(k) requirements when they meet the applicable general and specific limitations of the exemption.
The FDA classification database, updated September 14, 2026, lists both FLL (continuous measurement thermometer) and SDV (clinical electronic thermometer) under 21 CFR 880.2910.
For products covered by the FLL classification, the applicable FDA classification is:
- 21 CFR 880.2910 – Continuous measurement thermometer – FLL – Class II
For applicable intermittent clinical electronic thermometers that meet the exemption requirements:
- 21 CFR 880.2910 – Clinical electronic thermometer – SDV – Class II, 510(k) exempt
Hand sanitizers intended for use as antiseptic products are regulated by FDA as over-the-counter (OTC) drugs, rather than cosmetics. Alcohol-based hand sanitizers containing ethanol or isopropyl alcohol fall under FDA’s OTC drug framework. FDA’s current import alert for alcohol-based hand sanitizers confirms that these products are generally considered nonprescription OTC drug products.
Imported hand sanitizers must comply with applicable requirements under the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations. FDA verifies requirements such as drug establishment registration, drug listing, applicable drug applications, labeling, and current good manufacturing practices (CGMPs) when these products enter the United States. See FDA’s current requirements for importing human drugs for additional information.
FDA Information Required at Entry
Importers and entry filers must provide the FDA information applicable to the specific drug product. FDA reviews information submitted through the entry transmission, including the declared manufacturer, importer or consignee, product description, intended use, and applicable Affirmations of Compliance (A of C).
For human drug products, applicable A of C codes can include:
- REG – Drug Registration Number
- DLS – Drug Listing Number
- DA – Drug Application Number, when applicable
FDA explains that A of C codes help verify compliance during import review, although the specific codes required depend on the product and entry circumstances. Filers should consult FDA’s current human drug import requirements and the applicable ACE guidance when preparing an entry.
Foreign establishments that manufacture, repack, relabel, or salvage drugs for import into the United States must register with FDA when required. These establishments must also identify all known importers in their FDA registration. Finished drugs must also meet applicable drug listing requirements. FDA provides additional requirements for drug registration and listing.
Filing Entries of Hand Sanitizer
Hand sanitizer entries should be transmitted to FDA as OTC drug products, rather than as cosmetics, when the product meets the applicable definition of an OTC drug. FDA compares information submitted with an entry against its registration and listing records and other internal systems. Incorrect or incomplete information can delay entry review. FDA’s guidance on importing OTC drugs provides the current requirements for these products.
Filers should make sure the manufacturer, importer or consignee, product description, product code, intended use, and applicable A of C information accurately correspond to the product being imported. FDA’s guidance on common human drug entry errors also addresses mismatches involving drug listing numbers, registration numbers, and product declarations.
FDA Product Codes for Hand Sanitizers
The appropriate FDA product code depends on the product and its active ingredient. FDA’s current import alert for alcohol-based hand sanitizers lists the following examples:
Active Ingredient – FDA Product Code
- Ethyl alcohol (ethanol) – 62HAL05
- Isopropyl alcohol – 62FAL23
- Benzalkonium chloride – 62HAL99
Importers should verify the appropriate product code for the specific formulation before filing. FDA’s current import alert identifies ethanol and isopropyl alcohol as the active ingredients covered by its definition of alcohol-based hand sanitizers. It also lists the applicable FDA product codes for these products.
Current Regulatory Considerations
FDA continues to regulate alcohol-based hand sanitizers as OTC drugs. Products marketed in the United States must meet applicable requirements for lawful marketing, labeling, registration and listing, and CGMP compliance. FDA states that certain nonprescription hand sanitizers without an approved application may be marketed under section 505G(a)(3) of the FD&C Act when they meet the applicable conditions of the OTC monograph and other requirements.
FDA also monitors imported hand sanitizers for compliance and can place products under Detention Without Physical Examination (DWPE) when the agency identifies applicable violations. For example, FDA Import Alert 62-08 currently addresses alcohol-based hand sanitizers manufactured in Mexico and identifies conditions under which affected shipments may be detained.
Importers should review the applicable FDA requirements and current import alerts before shipping hand sanitizer products to the United States.
The COVID-19-era restrictions on exports of certain personal protective equipment (PPE) described in FEMA’s 2020 Temporary Final Rule (TFR) are no longer in effect. FEMA’s TFR established temporary controls on exports of certain scarce medical resources during the COVID-19 response, including certain N95 respirators, surgical masks, surgical gloves, and other air-purifying respirators. FEMA later extended the TFR through June 30, 2021. FEMA’s guidance for exporters of medical supplies and equipment documents the final period of the temporary export controls.
As a result, the former FEMA requirement for exporters to obtain an exemption or submit a letter of attestation through the Document Image System (DIS) for covered PPE shipments should not be treated as a current general export requirement.
Current PPE Export Requirements
U.S. exporters of PPE must comply with any export controls, licensing requirements, and other federal requirements that apply to the specific product and transaction. CBP notes that it enforces export requirements administered by other federal agencies, while the agency responsible for the commodity or control determines the applicable licensing requirements. CBP’s export license guidance provides information on the federal agencies that administer export controls.
Exporters should also submit required Electronic Export Information (EEI) through the Automated Export System (AES) when the shipment meets the applicable filing requirements. CBP identifies AES as the electronic system used to submit export information to CBP and the U.S. Census Bureau.
Because export controls can vary by product, destination, end user, and intended end use, exporters should check the applicable requirements before shipping PPE. Products that fall under the jurisdiction of the U.S. Department of Commerce’s Bureau of Industry and Security (BIS), the U.S. Department of State, or another federal agency may require a license or qualify for a license exception depending on the circumstances.
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