Importing Pandemic Provides Necessities Laid Out by Customs Dealer

Common Cargo’s home customs dealer, INLT gave a terrific webinar outlining the U.S. necessities round importing pandemic provides throughout this COVID-19 disaster. We thought what they shared could be a terrific useful resource for organizations attempting to get provides, whether or not private protecting gear (PPE) for people or medical provides for hospitals, to the U.S.

Chris Reynolds and the INLT group had been gracious sufficient to allow us to share their slides right here in Common Cargo’s weblog as a useful resource for you.

Beneath, you’ll be capable to see a picture of every slide, masking issues from FAQs to necessities and responsibility data on particular merchandise like masks, robes, and sanitizers to enforcement pointers on the difficulty.

All the knowledge on this publish was present as of March thirtieth, 2020, but it surely ought to be famous that issues are continually, typically each day, altering on the subject of guidelines and necessities across the worldwide transport of pandemic-related objects. Due to this, INLT warns that classifications and FDA rules ought to be confirmed together with your customs dealer or legal professional when really transport objects discovered inside this publish.

Nonetheless, the knowledge discovered beneath ought to be a really helpful useful resource.

Earlier than we get into the good things, we at Common Cargo would similar to to present a shout out and thanks to Chris Reynolds and the hard-working INLT group.

INLT’s Pandemic Provides Webinar Slides

inlt pandemic supplies FAQs

Continuously Requested Questions

U.S. import necessities for merchandise in-demand because of the COVID-19 pandemic

Present as of March 30, 2020

inlt pandemic supplies webinar disclaimers

The present novel coronavirus (COVID-19) pandemic evolves day-to-day as does the U.S. authorities’s regulatory response. Amazon, INLT, and its associates can not assure that the content material of this presentation displays the most recent federal authorized necessities.

The knowledge supplied on this presentation is common in nature and is supplied for instructional functions solely. It doesn’t represent authorized recommendation. Please seek the advice of with an legal professional in case you have questions on your particular authorized rights or duties, or your customs dealer for potential shipments.

This coaching shouldn’t be an alternative to studying the U.S. Harmonized Tariff Schedule, 21 C.F.R. Subchapter C, D, or H, 40 C.F.R. Elements 152-180, or some other federal rules.

inlt pandemic supplies webinar commodity requirements

Commodity Necessities

inlt pandemic supplies webinar surgical masks

Surgical Masks

HTSUS 6307.90.9889, 7%
Part 301 duties: exempt pursuant to 85 FR 15244

Regulated by FDA as a Class II Medical Gadget

If meant to supply liquid barrier safety

510(ok) requirement not enforced Product code: FXX

If not marketed or meant to be used as a medical machine

FDA rules don’t apply

INLT Pandemic Supplies Webinar Medical Masks

IMPORT REQUIREMENTS

Medical Masks

HTSUS 6307.90.9889, 7%
Part 301 duties: exempt pursuant to 85 FR 15244

Regulated by FDA as a Class II Medical Gadget

If meant for a medical goal and never meant to supply liquid barrier safety

510(ok) necessities and different FD&C Act necessities briefly should not enforced Product code: FXX

If not marketed or meant to be used as a medical machine

FDA rules don’t apply

INLT pandemic supplies webinar n95 respirators

IMPORT REQUIREMENTS

N95 Respirators

HTSUS 6307.90.9889, 7%
Part 301 duties: exempt pursuant to 85 FR 15244

Regulated by FDA as a Class II Medical Gadget

If marketed or meant to be used as a medical machine

Regulated by FDA beneath NIOSH requirements as a Class II Medical Gadget; CDC additionally acknowledged NIOSH commonplace equal requirements
Product code: MSH

If not marketed or meant to be used as a medical machine

FDA rules don’t apply

INLT Pandemic Supplies N95 Respirators

IMPORT REQUIREMENTS

N95 Respirators

If respirator accommodates replaceable filters

HTSUS 9020.00.9000, 2.5%
Part 301 duties: doesn’t seem on any printed lists

If respirator doesn’t include replaceable filters

HTSUS 6307.90.9889, 7%
Part 301 duties: exempt pursuant to 85 FR 15244

If marketed or meant to be used as a medical machine:

Regulated by FDA beneath NIOSH requirements as a Class II Medical Gadget; CDC additionally acknowledged NIOSH commonplace equal requirements
Product code: MSH

If not marketed or meant to be used as a medical machine

FDA rules don’t apply

INLT Pandemic Supplies Webinar Plastic Gloves

IMPORT REQUIREMENTS

Plastic Gloves

Surgical and medical use

HTSUS 3926.20.1010, free
Part 301 duties: Listing 4B, not at the moment energetic

Regulated by FDA as a Class I Medical Gadget

510(ok) required
Product codes: a number of primarily based on materials and use

INLT Pandemic Supplies Webinar Plastic Gloves Non Medical

IMPORT REQUIREMENTS

Plastic Gloves (not marketed or meant to be used as medical machine)

Seamless disposable gloves

HTSUS 3926.20.1020, free
Part 301 duties: Listing 4B, not at the moment energetic

Seamless gloves for repetitive use

HTSUS 3926.20.1050, free
Part 301 duties: Listing 4B, not at the moment energetic

Disposable gloves with seams

HTSUS 3926.20.4010, 6.5%
Part 301 duties: Listing 4B, not at the moment energetic

Repetitive use gloves with seams

HTSUS 3926.20.4050, 6.5%
Part 301 duties: Listing 4B, not at the moment energetic

INLT Pandemic Supplies Webinar Rubber Gloves 1

IMPORT REQUIREMENTS

Rubber Gloves Half I

Regulated by FDA as a Class I Medical Gadget
510(ok) required
Product code: a number of relying on materials and use

Surgical gloves of pure rubber

HTSUS 4015.11.0110, free
Part 301 duties: doesn’t seem on any printed lists

Surgical gloves of artificial rubber

HTSUS 4015.11.0150, free
Part 301 duties: doesn’t seem on any printed lists

INLT Pandemic Supplies Webinar Rubber Gloves 2

IMPORT REQUIREMENTS

Rubber Gloves Half II

Regulated by FDA as a Class I Medical Gadget
510(ok) required
Product code: a number of relying on materials and use

Medical gloves of pure rubber

HTSUS 4015.19.0510, free
Part 301 duties: exempt pursuant to 85 FR 13970

Medical gloves of artificial rubber

HTSUS 4015.19.0550, free
Part 301 duties: exempt pursuant to 85 FR 13970

INLT Pandemic Supplies Webinar Rubber Gloves 3

IMPORT REQUIREMENTS

Rubber Gloves Half III (not marketed or meant to be used as a medical machine)

Seamless disposable gloves

HTSUS 4015.19.1010, 3%
Part 301 duties: exempt pursuant to 85 FR 15015

Seamless gloves for repetitive use

HTSUS 4015.19.1050, 3% Part 301 duties: Listing 3, 25%

Gloves with seams, both disposable or repetitive use

HTSUS 4015.19.5000, 14% Part 301 duties: Listing 3, 25%

INLT Pandemic Supplies Webinar Gowns 1

IMPORT REQUIREMENTS

Robes Half I

Nonwoven disposable designed to be used in hospitals, clinics, laboratories or contaminated areas, manufactured from felt or nonwovens, whether or not or not impregnated, coated, coated, or laminated, together with spun-bonded.
HTSUS 6210.10.5000, free

Part 301 duties: exempt pursuant to 85 FR 13970
Most robes are regulated by FDA as a Class II Medical Gadget

Product codes

FME: examination robes
FYA: surgical robes
FYB: affected person robes
FYC: surgical isolation robes
OEA: non-surgical isolation robes
FXO: surgical swimsuit

INLT Pandemic Supplies Webinar Gowns 2

IMPORT REQUIREMENTS

Robes Half II

Different clothes not marketed or meant to be used as a medical machine, manufactured from felt or nonwovens, whether or not or not impregnated, coated, coated, or laminated, together with spun- bonded.

Overalls and coveralls

HTSUS 6210.10.9010, 16%
Part 301 duties: Listing 4B, not at the moment energetic

Different clothes

HTSUS 6210.10.9040, 16%
Part 301 duties: Listing 4B, not at the moment energetic

INLT Pandemic Supplies Webinar Isolation Suits & Biohazard Suits

IMPORT REQUIREMENTS

Isolation Fits & Biohazard Fits

Regulated by FDA as a Class II Medical Gadget Product code: FXO

Of plastic sheeting marketed or meant for medical use

HTSUS 3926.20.9050, 5%
Part 301 duties: excluded pursuant to 85 FR 15015

Of plastic sheeting and never marketed or meant for medical use (e.g. industrial or different common use)
HTSUS 3926.20.9050, 5%
Part 301 duties: excluded pursuant to 85 FR 15015

INLT Pandemic Supplies Webinar Thermometers

IMPORT REQUIREMENTS

Thermometers

Regulated by FDA as a Class II medical machine

Product codes

FLK: mercury thermometer
FLL: electrical thermometer

Liquid stuffed thermometer

HTSUS 9025.11.2000, free
Part 301 duties: doesn’t seem on any printed lists

Digital thermometers

HTSUS 9025.19.8040, free
Part 301 duties: if valued at not over $11 then excluded pursuant to 84 FR 52552, in any other case they seem on Listing 2, 25%

Hand Sanitizers

IMPORT REQUIREMENTS

Hand Sanitizers

Regulated by FDA as a drug

80% or extra by ethyl alcohol

HTSUS 2207.10.6090, 2.5% Part 301 duties: Listing 3, 25%

Liquid or gel, non-aromatic compounds (e.g. ethyl alcohol and isopropyl alcohol)

HTSUS 3808.94.5000, 5% Part 301 duties: Listing 3, 25%

Liquid or gel, fragrant compound (e.g. benzalkonium chloride)

HTSUS 3808.94.1000, 6.5% Part 301 duties: Listing 3, 25%

INLT Pandemic Supplies Webinar Surface Disinfectants

IMPORT REQUIREMENTS

Floor Disinfectants

Regulated by EPA as a pesticide

Hydrogen peroxide, put up on the market as a cleansing answer for surfaces

HTSUS 3808.94.5000, 5% Part 301 duties: Listing 3, 25%

Floor disinfectants, put up for retail sale containing fragrant compounds (e.g. benzalkonium chloride)
HTSUS 3808.94.1000, 6.5%
Part 301 duties: Listing 3, 25%

Floor disinfectants, put up for retail sale containing non-aromatic compounds (e.g. peroxyacids alcohol)
HTSUS 3808.94.1000, 6.5%
Part 301 duties: Listing 3, 25%

INLT Pandemic Supplies Webinar Medical Waste Bags

IMPORT REQUIREMENTS

Medical Waste Baggage

Not regulated by FDA

Of polyethylene with any aspect over 75mm in size

HTSUS 3923.21.0095, 3%
Part 301 duties: excluded pursuant to 85 FR 15015

Of different plastics

HTSUS 3923.29.000, 3% Part 301 duties: Listing 3, 25%

INLT Pandemic Supplies Webinar Wash Cloths

IMPORT REQUIREMENTS

Wash Cloths

Not regulated by FDA, until marketed for medical use

Microfiber cleansing cloths

HTSUS 6307.10.2030, 5.3% Part 301 duties: Listing 4A, 7.5%

Cotton cleansing cloths

HTSUS 6307.10.1090, 4.1% Part 301 duties: Listing 4A, 7.5%

INLT Pandemic Supplies Webinar FDA Regulations

FDA Laws
Enforcement Tips in Mild of COVID-19

INLT Pandemic Supplies Webinar FDA Overview

FDA Overview

The Meals and Drug Administration (FDA) is the federal company that enforces the Federal Meals, Drug, and Beauty Act (FD&C Act).

Merchandise qualifying as medical units or medicine can’t be imported or offered within the U.S. until they adjust to necessities of the FD&C Act.

INLT Pandemic Supplies Webinar Non-Medical Devices

Non-Medical Units

U.S. Customs and Border Safety issued the next steering for non-FDA-regulated private protecting gear (PPE) imported for common goal or industrial use:

PPE for common goal or industrial use, i.e. merchandise that aren’t meant to be used to forestall illness or sickness, should not regulated by FDA

PPE imports conforming to a common goal or industrial use can’t be imported if they’re meant to be distributed or marketed for medical use, absent compliance with relevant FDA necessities

INLT Pandemic Supplies Webinar Enforcement Policy for Face Masks and Respirators in Light of COVID-19 1

Enforcement Coverage for Face Masks and Respirators in Mild of COVID-19

In gentle of the COVID-19 pandemic and as of March 30, 2020, FDA has briefly modified its enforcement coverage for sure face masks and respirators. In an try to broaden the supply of common use face masks for most of the people and respirators for well being care professionals, FDA is not going to implement sure necessities beneath the FD&C Act with respect to those merchandise.

This selective enforcement coverage will stay in impact at some point of the COVID-19 public well being emergency as declared by the Division of Well being and Human Providers, however might change at any time.

INLT Pandemic Supplies Webinar Enforcement Policy for Face Masks and Respirators in Light of COVID-19 2

Enforcement Coverage for Face Masks and Respirators in Mild of COVID-19

THIS POLICY APPLIES TO

(See desk in picture above.)

INLT Pandemic Supplies Webinar Enforcement Policy for Face Masks and Respirators in Light of COVID-19 3

Enforcement Coverage for Face Masks and Respirators in Mild of COVID-19

Face masks meant for a medical goal, that aren’t meant to supply liquid barrier safety:

The place the face masks doesn’t create an undue danger in gentle of the general public well being emergency, these masks could be distributed each to most of the people and medical personnel with out compliance with:

510(ok) necessities—2.1 C.F.R. Half 807.81
Studies or corrects and removals—21 C.F.R. Half 806
Registration and Itemizing necessities—21 C.F.R. Half 807
And Distinctive Gadget Identification necessities—21 C.F.R. Half 830

High quality system regulation necessities—21 C.F.R. Half 820

As long as…

The product contains labeling that precisely describes the product as a face masks (as opposed as a surgical masks) and features a record of the physique contacting supplies (which doesn’t embrace any medicine or biologics)

The product contains labeling that recommends towards use in a surgical setting, or the place vital publicity to liquid, bodily or different hazardous fluids, could also be anticipated; use in a scientific setting the place the an infection danger stage via inhalation publicity is excessive

The product shouldn’t be meant for any use that might create an undue danger, for instance, the labeling doesn’t embrace customers for antimicrobial or antiviral safety or associated makes use of or makes use of for an infection prevention or discount or associated points and doesn’t embrace particulate filtration claims

INLT Pandemic Supplies Webinar Enforcement Policy for Face Masks and Respirators in Light of COVID-19 4

Enforcement Coverage for Face Masks and Respirators in Mild of COVID-19

Surgical masks meant to supply liquid barrier safety:

The place the face masks doesn’t create an undue danger in gentle of the general public well being emergency, these masks could be distributed and used with out prior submission of a premarket notification beneath part 510(ok) if:

The product meets fluid resistance testing (liquid barrier efficiency) in keeping with commonplace ASTM F1862

The product meets Class I or Class II flammability requirement per 16 CFR 1610 (until labeled with a suggestion towards use within the presence of excessive depth warmth supply or flammable gasoline)

The product contains labeling that precisely describes the product as a surgical masks and features a record of the physique contacting supplies (which doesn’t embrace any medicine or biologics)

The product shouldn’t be meant for any use that might create an undue danger, for instance the labeling doesn’t embrace makes use of for antimicrobial or antiviral safety or associated makes use of or makes use of for an infection prevention or discount or associated makes use of, and doesn’t embrace particulate filtration claims

INLT Pandemic Supplies Webinar FAQ

FAQ

Q: WHAT IS THE EUA ISSUED BY FDA FOR FACEMASKS?

Reply: On March 2, 2020, FDA issued an Emergency Use Authorization (EUA) in response to the inadequate provide of filtering facepiece respirators (FRRs). The EUA applies to:

All FRRs accredited by the Nationwide Institute for Occupational Security and Well being (NIOSH) as non-powered air-purifying particulate FFRs
All NIOSH accredited FRRs which have handed the producers’ really helpful shelf-life to be used in healthcare settings

MORE INFO

The EUA applies principally to producers and strategic stockpilers of these things.
Producers and stockpilers can request authorization from FDA to distribute these FRRs to healthcare personnel solely regardless that they don’t adjust to federal rules.
FRRs distributed beneath this EUA can’t be utilized by most of the people.
On March 24, 2020, FDA issued a second EUA permitting for the distribution of sure non-NIOSH-approved FRRs as long as they had been manufactured in particular non-U.S. jurisdictions to particular requirements and/or have advertising authorization in sure non-U.S. regulatory jurisdictions. Authorization permits these merchandise to be distributed to healthcare personnel solely.

INLT Pandemic Supplies Webinar Thank You